1

COMPARISON BETWEEN MAGNESIUM SULFATE AND

DEXMEDETOMIDINE IN CONTROLLED HYPOTENSION DURING

FUNCTIONAL ENDOSCOPIC SINUS SURGERY

Dissertation submitted to the

THE TAMIL NADU DR.M.G.R. MEDICAL UNIVERSITY

in partial fulfilment for the award of the degree of

DOCTOR OF MEDICINE

In

Anaesthesiology

BRANCH X

INSTITUTE OF ANAESTHESIOLOGY AND CRITICAL CARE

MADRAS MEDICAL COLLEGE

CHENNAI-600003

May 2020

Registration number - 201720016

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CERTIFICATE OF THE GUIDE

This is to certify that the dissertation titled “COMPARISON BETWEEN

MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN CONTROLLED

HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY”

is a bonafide research work done by Dr. SRIRAM SUNDAR. M in partial fulfilment

of the requirement for the degree of DOCTOR MEDICINE in Anaesthesiology.

Prof. Dr. Vellingiri M, M.D., D.A.,

Professor of Anaesthesiology,

Institute of Anaesthesiology and Critical Care,

Rajiv Gandhi Govt. General Hospital,

Madras Medical College,

Chennai -03.

DATE:

PLACE:

3

CERTIFICATE

This is to certify that the dissertation titled, “COMPARISON BETWEEN

MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN CONTROLLED

HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY”

submitted by DR. SRIRAM SUNDAR. M with registration number 201720016 in

partial fulfilment for the award of the degree of DOCTOR OF MEDICINE in

anaesthesiology by The Tamilnadu Dr.M.G.R medical university, Chennai is a

bonafide record of work done by him in the INSTITUTE OF ANAESTHESIOLOGY

& CRITICAL CARE, Madras Medical College, during the academic year 2017 -2020

.

Prof.Dr.ANURADHA SWAMINATHAN, Prof.Dr.JAYANTHI,

MD., DA., M.D., F.R.C.P(Glasg).,

Professor and Director, The Dean,

Institute of Anaesthesiology & Critical Care, Madras Medical College,

Madras Medical College, Rajiv Gandhi Govt. General

Rajiv Gandhi Govt General Hospital, Hospital,

Chennai – 600003. Chennai – 600003.

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DECLARATION

I hereby declare that the dissertation titled, “COMPARISON BETWEEN

MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN CONTROLLED

HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS

SURGERY” has been prepared by me under the guidance of PROF.DR.

VELLINGIRI M, M.D., D.A., Professor of Anaesthesiology, INSTITUTE OF

ANAESTHESIOLOGY AND CRITICAL CARE, MADRAS MEDICAL

COLLEGE, CHENNAI, in partial fulfilment of the regulations for the award of

the degree of M.D (Anaesthesiology),examination to be held in May 2020. This

study was conducted at INSTITUTE OF ANAESTHESIOLOGY AND

CRITICAL CARE, MADRAS MEDICAL COLLEGE, CHENNAI.

I have not submitted this dissertation previously to any journal or any

university for the award of any degree or diploma.

DR. SRIRAM SUNDAR. M

Date:

Place: Chennai

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ACKNOWLEDGEMENT

I am extremely thankful to DR. JAYANTHI M.D., FRCP(Glasg)., Dean,

Madras Medical College, for her permission to carry out this study. I am immensely

grateful to PROF. DR. ANURADHA SWAMINATHAN, M.D., D.A., Director

and Professor, Institute of Anaesthesiology and Critical Care, for her concern and

support in conducting this study.

I am extremely grateful and indebted to my guide PROF. DR. VELLINGIRI,

MD., D.A., Professor, Institute of anaesthesiology and critical care for his concern,

inspiration, meticulous guidance, expert advice and constant encouragement in doing

and preparing this dissertation.

I am extremely thankful to my Assistant Professor DR. RAVI, DR. ASHA and

DR. RAJESHWARI for their constant motivation and valuable suggestions in doing

my study.

I am thankful to the Institutional Ethical Committee for their guidance and

approval for this study.

I am thankful to all my colleagues and friends for their help and advice in

carrying out this dissertation.

I am immensely thankful to all the patients who consented, without whom this

study couldn’t have been possible.

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CONTENTS

S.NO. INDEX PAGE NO

1. INTRODUCTION 1

2. AIMS AND OBJECTIVES 24

3. REVIEW OF LITERATURE 25

4. MATERIALS AND METHODS 40

5. OBSERVATON, RESULTS AND ANALYSIS 45

6. SUMMARY 75

7. DISCUSSION 76

8. CONCLUSION 78

9. BIBLIOGRAPHY 79

10. ANNEXURE

a.Ethical committee approval

b.Antiplagiarism – URKUND copy

c.Plagiarism certificate

d.Proforma

e.Patient Consent Form

f.Patient Information Form

g.Master Chart

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INTRODUCTION

Functional endoscopic sinus surgery is a commonly performed surgery

worldwide for various indications. It is the preferred surgical treatment for chronic

rhinosinusitis. In part due to being an endoscopic procedure and in part due to being a

procedure done in an enclosed space, bleeding during functional endoscopic sinus

surgery is a major detriment to visibility during the procedure. In addition to that,

excessive bleeding might result in prolonged surgery, hypotension and might require

blood transfusion, associated with its own demerits. Anaesthesiologists find it

imperative to reduce bleeding during functional endoscopic sinus surgery to improve

visibility. One of the techniques used is controlled hypotension. By carefully reducing

the blood pressure, one can decrease blood loss and need for blood transfusion,

improve surgical site visibility.

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DEXMEDETOMIDINE

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Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist. Its

multitude of effects include sedation, anxiolysis, and analgesia without respiratory

depression. It also has synergistic action on the anaesthesia produced by other

anaesthetic drugs. Chemical name of Dexmedetomidine is (+)-4-(2,3

dimethylephenyl) ethyl – 1 H-imidazole monohydrochloride. Its molecular weight is

236.7 g/mol. Dexmedetomidine is the dextrorotatory S-enantiomer of medetomidine.

C13H16HCl is its empirical formula. [29]

Pharmacodynamics

Alpha 2 receptor agonists act on G-protein coupled alpha 2 receptors (3

subtypes – α2A, α2B, α2C) and produce different pharmacological activities. These

receptor subtypes are found in central, peripheral and autonomic nervous systems,

vital organs and blood vessels. Compared to clonidine, Dexmedetomidine is 8 to 10

times more selective towards α2A receptors (1620:1). Sedation may be due to its

action on post-synaptic α2 receptors. Dexmedetomidine also acts on beta adrenergic,

muscarinic, dopaminergic and serotonin receptors, but with low affinity. Analgesia is

believed to be due to action on α2 receptors of spinal cord. Higher affinity to α2

receptor selectively leads to bradycardia and vasodilatation because of vagomimetic

action.

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Pharmacokinetics

Following intravenous administration, dexmedetomidine shows rapid

redistribution. The distribution t1/2 of dexmedetomidine is 6 minutes and a terminal

elimination t1/2 is approximately 2 hours. Protein binding capacity of

dexmedetomidine is 94%. Volume of distribution is 118L.

It exhibits poor oral bioavailability because of first pass metabolism.

Metabolism is by direct glucuronidation (major pathway) as well as cytochrome p450

mediated. Excretion is through urine and feces. It may need dose reduction in various

degrees of renal and hepatic impairment.

Availability and Routes of administration

Dexmedetomidine is available as Dexmedetomidine Hydrochloride injections,

50 µg/0.5ml, 100 µg/ml and 200 µg/2ml. Various routes of administration such as

intravenous, intramuscular, spinal, epidural, peripheral nerve blocks, buccal and

intranasal routes have been described.[5,12,20,36]

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Clinical Applications

1. Premedication

Dexmedetomidine is extremely useful as a premedication as it exhibits

sedative, analgesic and anxiolytic effects. Dose is 0.3-0.6 µg/kg iv given 15

minutes before surgery

2. Sedation

Dexmedetomidine has been described for sedation in both ICU and procedural

sedation. In ICU, Dexmedetomidine is indicated in mechanically ventilated

patients where it decreases the requirement of opioids while causing minimal

respiratory depression. It has been safely used in Transesophageal

echocardiography [13], colonoscopy [24], awake carotid endarterectomy [7],

shockwave lithotripsy [25], vitreoretinal surgery [18], MRI and CT scan in

paediatric patients. It has the major advantage of minimum respiratory

depression. Usual dose is 1 µg/kg in 100ml saline given over 10 minutes

followed by 0.2-0.7 µg/kg/hr.

3. Adjuvant in regional techniques

Dexmedetomidine is highly lipophilic which allows rapid absorption into CSF

and binding to α2 receptors on spinal cord. Duration of both sensory and motor

blockade induced by local anaesthetics has been prolonged by

dexmedetomidine irrespective of route of administration, spinal, caudal,

epidural, peripheral nerve block.

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4. Controlled hypotension

Dexmedetomidine is a safe agent for controlled hypotension. Mechanism of

action is by action on both central and peripheral α2 receptors resulting in

decrease in norepinephrine release and subsequent decrease in Arterial

pressure, heart rate and cardiac output. Its ease of administration, predictability,

apparently less toxic side effects and maintenance of vital organs perfusion

makes it a near ideal hypotensive agent.

5. Attenuation of response to tracheal intubation and extubation

Due to its sympatholytic action, Dexmedetomidine attenuates hemodynamic

stress response to tracheal intubation and extubation. [20]

6. Anaesthetic sparing effect

Intraoperatively, dexmedetomidine decreases requirement of anaesthetic agents

due to its sedative effects. Both intravenous and inhalational anaesthetic agents

are required in lesser amounts

7. Cardiac surgery

In addition to attenuation of stress response, dexmedetomidine appears to

reduce the extent of myocardial ischemia during cardiac surgery. It has been

found to be useful in CABG, vascular surgery and thoracic surgery.

8. Neurosurgery

Dexmedetomidine provides protection against sudden increase in intracranial

pressure. It has neuroprotective effects that are valuable during cerebral

ischemia. It has been used in cases requiring spinal monitoring by evoked

potentials by substituting for neuromuscular blocking agents. It has also been

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extensive used in the sedation phases of awake craniotomy for resection of

tumours/epileptic foci near important areas.

9. Awake intubation

Use of dexmedetomidine has been described for awake fibreoptic intubation for

securing the difficult airway. [8]

10. Postoperative analgesia

Dexmedetomidine provides very good postoperative analgesia. It reduces

postoperative analgesic requirement significantly.

11. Other uses

Dexmedetomidine has also been described as useful in paediatric patients,

obese patients, alcohol and drug withdrawal, as an antishivering agent,

intraarticularly, in palliative care and chronic pain management.

Adverse effects

Common adverse effects are

Hypotension

Hypertension

Bradycardia

Dry mouth

Nausea

Reversal

Atipamezole is an α2 receptor antagonist which reverses the sedative and

sympatholytic actions of dexmedetomidine in a dose dependent manner. [32]

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MAGNESIUM SULFATE

Magnesium is an important component of many physiologic processes.

It has long been used in the field of anaesthesia and pain medicine. Magnesium is 4th

most common cation after sodium, potassium and phosphorus. Normal plasma range

is 1.4-2.2 mEq/L (0.7-1.1 mmol/L). Most important action of magnesium is blockade

of NMDA receptors and calcium channels. [16]

Physiological role

1. Acts as mediator for Na+/K+ pump, thereby maintaining transmembrane

potential

2. Generation of cyclic AMP via adenylyl cyclase

3. Release and action of parathyroid hormone

4. Oxidative phosphorylation, glucose utilization and protein synthesis

Homeostasis

Maintained by gastrointestinal absorption and renal excretion. Available in

diet. Mainly excreted by the kidneys, reabsorbed in the ascending loop of Henle.

Aldosterone inhibits renal excretion while parathormone increases gut absorption as

well as decreases renal excretion.

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System wise effects

1. Cardiovascular system

a. Direct depressant effect on myocardial and vascular smooth muscle.

b. Competes with Calcium at the presynaptic calcium channels and inhibits

release of catecholamines from the adrenal medulla, peripheral

adrenergic terminals and blocks adrenergic receptors directly as well.

c. Thus reducing pulmonary and systemic vascular resistance and causing

hypotension.

d. Slows the rate of SA node, prolongs SA conduction, prolongs PR

interval and refractory period of AV node. – Mechanism of

antiarrhythmic action

2. Nervous system

a. Reduces the release of acetylcholine at the neuromuscular junction by

competing with calcium at the presynaptic region.

b. Reduces excitability of nerves

c. Anticonvulsant

d. Reverses cerebral vasospasm

3. Musculoskeletal

a. Decrease release of acetyl choline

b. Causes termination of contraction, thereby marks the beginning of

relaxation in skeletal muscles

c. Muscle weakness in excessive concentrations

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4. Respiratory system

a. Magnesium behaves as an effective bronchodilator without affecting

respiratory drive

b. Respiratory failure in excessive concentrations.

5. Genitourinary system

a. Magnesium is a powerful tocolytic which decreases uterine tone and

contractility.

b. Mild diuretic properties

6. Hematological system

a. Reduces platelet activity resulting in prolonged bleeding time

Hypomagnesemia

Occurs frequently after surgery such as

cardiac surgery,

abdominal surgery

and orthopaedic surgery.

Other causes include,

decreased dietary intake or absorption,

hemodilution,

drug induced (diuretics, digoxin, cyclosporine etc),

hyperaldosteronism,

Diarrhoea,

NG drainage,

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hyperparathyroidism and

insulin administration.

Signs and symptoms include

chest pain,

palpitations,

arrhythmias,

muscle cramps,

stridor,

psychiatric disturbances and

ECG changes (PR prolongation and QT prolongation).

Treatment includes dietary supplementation and intravenous administration

(Magnesium sulfate contains 2 ml of 50% w/v solution – 1g / 2ml or 4mmols/2 ml).

Hypermagnesemia

Most common cause is iatrogenic as a result of intravenous therapy,

particularly in the setting of coexisting impaired renal excretion. Rarely may be due to

diabetic ketoacidosis and tumour lysis syndrome.

Clinical features are dependent on serum concentration.

4-5 mmol/L – Muscle weakness and loss of tendon reflexes

5-7.5 mmol/L respiratory paralysis

10-12.5 mmol/L cardiac arrest

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Management includes

careful monitoring during intravenous administration of magnesium,

cessation of therapy,

intravenous fluids,

diuretics,

dialysis

Calcium gluconate intravenously

Clinical Uses

1. Eclampsia

Extensive research has given Magnesium sulfate the prime place in

management of eclamptic seizures. Mechanism for the same has not yet been

established. Possible mechanisms include

Cerebral vasodilatation

Blood brain barrier protection

Various anticonvulsant actions

2. Analgesia

Magnesium has been found to be an excellent adjuvant to most analgesic

agents, despite not being a primary analgesic by itself. Its action is believed to

be due to its blockade of NMDA receptors. Intraoperative magnesium sulfate

has been associated with decreased opioid requirement in the postoperative

period. Magnesium sulfate has also been indicated in regional anaesthesia via

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both intravenous and intrathecal route. Magnesium sulfate prolongs the

duration of analgesia following spinal anaesthesia.

3. Anaesthesia sparing effect

Due to its sedative effect, Magnesium sulfate has synergistic action and

decreases requirement of both intravenous and inhalational anaesthetic agents.

4. Potentiating nondepolarising neuromuscular blocking drugs

Due to its competitive antagonism of Ca++ at the presynaptic calcium channel

and subsequent decrease in acetylcholine release, Magnesium sulfate

potentiates neuromuscular blockade by non depolarising neuromuscular

blocking agents. In cases where neuromuscular blocking agents requirement is

increased, like, cerebral palsy, burns, intake of sodium valproate, Magnesium

sulfate helps in reducing the requirement of neuromuscular blocking agents

5. Shivering

Magnesium sulfate decreases the incidence of shivering by 70-90% [30].

Shivering increases oxygen consumption and postoperative discomfort which

can be prevented by use of magnesium sulfate

6. Attenuation of tracheal response

Magnesium sulfate decreases sympathetic neurotransmitter release by

competitively blocking presynaptic calcium channel, thereby decreasing

hemodynamic pressor response to various stresses like tracheal intubation,

extubation and laparoscopy. This property of magnesium sulfate is of particular

importance in preeclamptic, eclamptic, hypertensive and cardiac patients.

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7. Controlled hypotension

Apart from decreasing sympathetic neurotransmitter release, Magnesium also

causes arterial dilatation by maintaining calcium inside the sarcoplasmic

reticulum. Major advantage of magnesium sulfate being maintenance of cardiac

output by maintaining β adrenergic activity (in presence of catecholamines) and

venous return.

8. Other uses due to sympatholysis

The sympatholytic actions of magnesium sulfate also makes it useful in

intraoperative hypertensive emergencies, management of a patient of

pheochromcytoma and severe tetanus

9. Antiarrhythmic

Even though magnesium sulfate is indicated only for Torsades de pointes, it is

also useful in other arrhythmias, particularly catecholamine induced

tachyarrhythmias and arrhythmias after cardiac surgery.

10. Status asthmaticus

Magnesium sulfate also has bronchodilatory properties which makes it one of

the last options during status asthmaticus not responding to usual management

strategies

11. Tocolytic

Magnesium sulfate has also been described as having tocolytic actions.

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CONTROLLED HYPOTENSION

Deliberately induced hypotension to reduce bleeding and to improve surgical

site visibility is called controlled hypotension. There is no fixed definition of

hypotension. It has been reported that there are 140 definitions of hypotension in

literature [9]. Most commonly described as reduction of systolic blood pressure to 80-

90mmHg or reduction of mean arterial pressure to 50-65mm Hg or a 30% reduction

from baseline MAP [15]. There has also been reports that decreases of 10-20% from

baseline MAP has been enough to decrease blood loss [11].

Indications

1. Cerebral aneurysm repair

2. Brain tumour resection

3. Endoscopic nasal surgeries

4. Middle ear surgeries

5. Total hip arthroplasty

6. Radical neck dissection

7. Radical cystectomy

8. Spine surgeries

9. Microscopic surgeries

10. Contraindications to transfusion (Non availability of blood, Jehovah’s witness etc)

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Techniques

1. Positioning (Reverse trendelenberg for head and neck surgeries)

2. PEEP

3. Regional anesthesia – Central neuraxial blockade

4. Pharamacological therapy

Ideal pharmacological agent – properties

1. Ease of administration

2. Predictable and dose dependent effect

3. Rapid onset/offset – Titratability

4. Quick elimination/ no toxic metabolites

5. Minimal effects on blood flow to vital organs

Agents

1. Inhalational agents

Mechanism of action – Inhalational anaesthetic agents decrease myocardial

contractility and cause systemic vasodilatation in a dose dependent manner.

Disadvantage – Decreases cardiac output

Cerebral vasodilation

2. Nitrodilators

Mechanism of action – Gives nitric oxide which activates guanylyl cyclase

and cGMP and produce vasodilatation

a. Sodium Nitroprusside

Disadvantage – Cyanide toxicity,

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Methemoglobinemia,

Coronary steal phenomenon,

Cerebral vasodilatation,

Abolishes hypoxic pulmonary vasoconstriction

b. Nitroglycerine

Disadvantage – Methemoglobinemia

Cerebral vasodilatation

Decrease hypoxic pulmonary vasoconstriction

Tachycardia – increased myocardial oxygen demand

3. Hydralazine

Disadvantage – Late onset, difficult to titrate

Cerebral vasodilatation

4. Fenoldopam

Disadvantage – Late onset, difficult to titrate

Increased intraocular pressure

5. Calcium channel blockers

a. Nicardipine

b. Clevidipine

6. ACE I inhibitors – Enalaprilat

7. α2 agonists

a. Clonidine

b. Dexmedetomidine

8. Magnesium sulfate

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Contraindications

1. Severe anemia

2. Hypovolemia

3. Coronary artery disease

4. Atherosclerosis

5. Peripheral vascular disease

6. Hepatic disease

7. Renal disease

8. Cerebrovascular disease

9. Uncontrolled glaucoma

Complications

1. Cerebral thrombosis

2. Paraplegia – decreased spinal cord perfusion

3. Acute kidney injury

4. Massive hepatic necrosis

5. Myocardial ischemia

6. Cardiac arrest

7. Metabolic acidosis

8. Blindness – Retinal artery thrombosis/Ischemic optic neuropathy

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FUNCTIONAL ENDOSCOPIC SINUS SURGERY

FESS is a commonly performed ENT procedure for medically refractory

chronic rhinosinusitis and chronic polyps. It is done using an endoscope in a small

restricted area making bleeding a major impediment to the procedure

Choice of anaesthesia – Local vs General anaesthesia

FESS in the early period was done under local anaesthesia, as the patient can

alert the surgeon which can minimise trauma and complications. In current times,

evolution of technique has allowed the surgeon to be more aggressive in extent of

resection. Advantages of general anaesthesia include

1. Immobile surgical field

2. Effective airway protection

3. Adequate analgesia

4. Patient comfort

Minimising bleeding

Haemorrhage decreases surgical site visibility and is directly responsible for

procedural failure, prolonged surgery and increased risk of vascular, orbital and

intracranial complications. Hence, minimising bleeding becomes an important

responsibility of the anaesthesiologist. Surgical control of the bleeding is difficult

because of the extensive vascular supply in the region. Methods to decrease bleeding

include

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Positioning

Reverse trendelenburg position upto 15º allows for venous decongestion of

head and neck regions aided by gravity.

Preoperative steroids

This is usually done in cases of severe polyposis as steroids have anti-

inflammatory action and decrease mucosal oedema

Injected and topical local anaesthetics and vasoconstrictors

Commonly used vasoconstrictors include cocaine, epinephrine and

phenylephrine.

Maintenance of anaesthesia depth

Coughing or straining of the patient will increase in mean arterial pressure and

increase in intrathoracic pressure thereby causing venous congestion in the upper part

of the body.

Controlled hypotension

Deliberately induced hypotension decreases capillary hydrostatic pressure

thereby decreasing capillary bleeding.

Attenuation of hemodynamic response to intubation and extubation

Sympathetic release in response to intubation and extuabtion will increase the

arterial pressure which will lead to increased bleeding.

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Smooth emergence and reversal

Avoidance of straining will decrease post surgical bleeding, decrease the risk of

sore throat and patient discomfort. Decision must be made regarding the mode of

extubation – awake vs deep. Even though deep extubation prevents the stress induced

increase in post surgical bleeding, it increases the risk of aspiration and obstruction.

[35]

Postoperative nausea and vomiting

Contributing factors include

1. Blood in the stomach

2. Inflammation of uvula and throat

3. Use of opioids for pain control

Can be prevented by

1. Packing of throat

2. Decompression of stomach using orogastric tube before extubation

3. Prophylaxis with ondansetron and dexamethasone

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ASSESSMENT OF BLEEDING IN FESS

Assessment of bleeding in FESS can be done by using the scale described by Fromme

et al [18] and Boezaart et al [10]. Evaluation is based on 6 point scale.

0 – No bleeding

1 – Mild bleeding, suction not necessary

2 – Mild bleeding, occasional suctioning required, non threatened surgical field

3 – Mild bleeding, frequent suctioning required, bleeding threatens surgical field few

seconds after suction

4 – Moderate bleeding, frequent suctioning required, bleeding threatens surgical site

immediately after suction

5 – Severe bleeding, continued suction needed, bleeding appears faster than it can be

removed by suction

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MODIFIED RAMSAY SEDATION SCALE

SCORE CHARACTERISTICS

1 Awake and alert, minimal or no cognitive impairment

2 Awake but tranquil, purposeful responses to verbal commands at

conversational level

3 Appears asleep, purposeful responses to verbal commands at

conversational level

4 Appears asleep, purposeful responses to verbal commands but at

louder than conversational level or light glabellar tap

5 Asleep, sluggish purposeful responses only to loud verbal

commands or strong glabellar tap

6 Asleep, sluggish purposeful response only to painful stimuli

7 Asleep, reflex withdrawal to painful stimuli only

8 Unresponsive to external stimuli, including pain

2-3 Minimal sedation

4-5 Moderate sedation

6-8 Deep sedation [14]

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AIMS AND OBJECTIVES

To compare blood loss and surgical site visibility using controlled hypotension

by dexmedetomidine and magnesium sulfate during functional endoscopic sinus

surgery

SECONDARY OBJECTIVES

To compare

1. Satisfaction of the surgeon

2. Time taken to achieve desired mean arterial pressure

3. Total need of muscle relaxants

4. Attenuation of hemodynamic response to intubation and extubation

5. Postoperative sedation

6. Adverse effects

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REVIEW OF LITERATURE

1. Adnan Bayram, Ayse Ulgey, Isin Gunes, Ibrahim Ketenci, Ayse Capar, Aliye

Esmaoglu, Adem Boyaci.

COMPARISON BETWEEN MAGNESIUM SULFATE AND

DEXMEDETOMIDINE IN CONTROLLED HYPOTENSION DURING

FUNCTIONAL ENDOSCOPIC SINUS SURGERY. Revista Brasileira De

Anestesiologia. 2015;65(1):61-67.

They conducted the study in 60 patients and concluded that the use of

dexmedetomidine at the doses mentioned in this study provided more effective

and stable controlled hypotension in patients undergoing Functional endoscopic

sinus surgery, besides increasing the surgeon’s satisfaction and the quality of

the surgical site, without prolonging the recovery period.

26

2. Akcan Akkaya, Umit Yasar Tekelioglu, Abdullah Demirhan, Murat Bilgi, Isa

Yildiz, Tayfun Apuhan, Hasan Kocoglu.

COMPARISON OF EFFECTS OF MAGNESIUM SULFATE AND

DEXMEDETOMIDINE ON SURGICA VISION QUALITY IN

ENDOSCOPIC SINUS SURGERY, Revista Brasileira de Anestesiologia,

Volume 64, No. 6, Nov-Dec 2014, DOI: 10.1016/j.bjane.2014.01.008

They conducted the study in 60 patients and concluded that due to its reduction

of bleeding and heart rate in endoscopic sinus surgery and its positive impacts

on the duration of surgery, we consider dexmedetomidine to be a good

alternative to magnesium

27

3. Omyma S.M. Khalifa, Osama G. Awad.

A COMPARATIVE STUDY OF DEXMEDETOMIDINE, MAGNESIUM

SULFATE OR GLYCERYL TRINITRATE IN DELIBERATE

HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC SINUS

SURGERY. Ain-Shams Journal of Anesthesiology, 2015, 08:320-326, DOI:

10.4103/1687-7934, 161692

They conducted the study in 60 patients and concluded that Dexmedetomidine,

Magnesium sulfate or glyceryl trinitrate induced deliberate hypotension, with

superior hemodynamic stability in dexmedetomidine. Analgesic and sedative

effects were obtained with dexmedetomidine and magnesium sulfate, but with

longer recovery and discharge times.

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4. Hesameddin Modir, Amirreza Modir, Omid Rezaei, Abolfazi Mohammadbeigi.

COMPARING REMIFENTANIL, MAGNESIUM SULFATE AND

DEXMEDETOMIDINE FOR INTRAOPERATIVE HYPOTENSION AND

BLEEDING AND POSTOPERATIVE RECOVERY IN ENDOSCOPIC

SINUS SURGERY AND TYMPANOMASTOIDECTOMY. Med Gas Res.

2018 Apr-Jun; 8(2): 42-47, DOI: 10.4103/2045-9912.235124.

They conducted the study in 105 patients and concluded that the reduced

BP/HR, blood loss and the overall amount of propofol administered during

surgery in the dexmedetomidine group when compared to the other groups

indicates dexmedetomidine seems to be an effective choice with longer

postoperative recovery time.

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5. Hyunzu Kim, Sang-Hee Ha, Chang-Hoon Kim, Sang-Hoon Lee, Seung-Ho

Choi.

EFFICACY OF INTRAOPERATIVE DEXMEDETOMIDINE INFUSION ON

VISUALIZATION OF THE SURGICAL FIELD IN ENDOSCOPIC SINUS

SURGERY. Korean J Anesthesiol. 2015 Oct; 68(5): 449-454, DOI:

10.4097/kjae.2015.68.5.449

They conducted the study in 43 patients and concluded that continuous

infusions of dexmedetomidine provide a similar visualisation of the surgical

field and hemodynamic stability as remifentanil target-controlled infusions in

patients undergoing endoscopic sinus surgery

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6. Guven DG, Demiraran Y, Sezen G, Kepek O, Iskender A.

EVALUATION OF OUTCOMES IN PATIENTS GIVEN

DEXMEDETOMIDINE IN FUNCTIONAL ENDOSCOPIC SINUS

SURGERY. Ann Otol Rhinol Laryngol. 2011 Sep;120(9):586-92.

They conducted the study in 40 patients and concluded that intraoperative

bleeding, hemodynamic stability and VAS scores were better and the side

effects were less frequent in the dexmedetomidine group than control group.

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7. Ossama H. Aboushanab, Ahmed M. El-Shaarawy, Ahmed M. Omar, Hisham

H. Abdelwahab.

A COMPARATIVE STUDY BETWEEN MAGNESIUM SULFATE AND

DEXMEDETOMIDINE FOR DELIBERATE HYPOTENSION DURING

MIDDLE EAR SURGERY. Egyptian Journal of Anaesthesia, 27:4, 227-232,

DOI: 10.1016/j.egja.2011.07.008

They conducted the study in 88 patients and concluded that both magnesium

sulfate and dexmedetomidine successfully induced deliberate hypotension and

good surgical field visibility but magnesium sulfate was associated with shorter

recovery time and earlier discharge from the PACU

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8. Rabie Soliman, Eman Fouad.

THE EFFECTS OF DEXMEDETOMIDINE AND MAGNESIUM SULFATE

IN ADULT PATIENTS UNDERGOING ENDOSCOPIC TRANSNASAL

TRANSSPHENOIDAL RESECTION OF PITUITARY ADENOMA. Indian

Journal of Anaesthesia, 2017, Volume 61, Issue 5, Pages 410-417

They conducted the study in 152 patients and concluded that during

transsphenoidal pituitary resection, dexmedetomidine, compared to magnesium

sulfate is associated with lower blood loss and better operating conditions but

with more hypotension and bradycardia.

33

9. Ahmed Abdel Hakim Balata, Howaida Kamal Abdel Latif, Salwa Hassan

Waly, Ahmed Bahgat Mohamed.

DEXMEDETOMIDINE VERSUS MAGNESIUM SULFATE OR

LIDOCAINE FOR BLUNTING STRESS RESPONSE TO DIRECT

LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN

ABDOMINAL SURGERIES. Z.U.M.J.Vol. 24, No. 6, November 2018, DOI:

10.21608/zumj.2018.18288

They conducted the study in 87 patients and concluded that dexmedetomidine

and magnesium sulfate play an important role in blunting the stress response

resulting from direct laryngoscopy and intubation.

34

10. N.M. Elsharnouby, M.M. Elsharnouby.

MAGNESIUM SULFATE AS A TECHNIQUE OF HYPOTENSIVE

ANAESTHESIA. British Journal of Anaesthesia, Volume 96, Issue 6, June

2006, Pages 727-731.

They conducted the study in 60 patients and concluded that Magnesium sulfate

led to a reduction in arterial pressure, heart rate, blood loss and duration of

surgery. Furthermore, magnesium infusion alters anaesthetic dose requirements

and emergence time.

35

11. Ryu JH, Sohn IS, Do SH

CONTROLLED HYPOTENSION FOR MIDDLE EAR SURGERY: A

COMPARISON BETWEEN REMIFENTANIL AND MAGNESIUM

SULFATE. Br J Anaesth. 2009;103:490-495

They conducted the study in 80 patients and concluded that both magnesium

sulfate and remifentanil when combined with Sevoflurane provided adequate

controlled hypotension and proper surgical conditions for middle ear surgery.

However, patients administered magnesium sulfate had a more favourable

postoperative course with better analgesia and less shivering and PONV

36

12. Salmasi, V, Maheshwari, K, Yang, D, Mascha, EJ, Singh, A, Sessler, DI, Kurz,

A RELATIONSHIP BETWEEN INTRAOPERATIVE HYPOTENSION, DEFINED

BY EITHER REDUCTION FROM BASELINE OR ABSOLUTE THRESHOLDS,

AND ACUTE KIDNEY AND MYOCARDIAL INJURY AFTER NONCARDIAC

SURGERY: A RETROSPECTIVE COHORT ANALYSIS. ANESTHESIOLOGY

2017; 126:47–65

They conducted a retrospective cohort study and concluded that the

associations based on relative thresholds were no stronger than those based on

absolute thresholds. Furthermore, there was no clinically important interaction with

preoperative pressure. Anaesthetic management can thus be based on intraoperative

pressures without regard to preoperative pressure.

37

13. Song JW, Lee YW, Yoon KB, et al.

MAGNESIUM SULFATE PREVENTS REMIFENTANIL-INDUCED

POSTOPERATIVE HYPERALGESIA IN PATIENTS UNDERGOING

THYROIDECTOMY. ANESTH ANALG. 2011;113:390---7.

They conducted the study in 90 patients and concluded that a relatively high dose of

intraoperative remifentanil enhances periincisional hyperalgesia. Intraoperative

magnesium sulfate prevents remifentanil induced hyperalgesia. However,

hyperalgesia did not reach clinical relevance in terms of postoperative pain or

analgesic consumption in patients undergoing thyroidectomy.

38

14. Pei Yu Tan, Ruban Poopalalingam,

ANAESTHETIC CONCERNS FOR FUNCTIONAL ENDOSCOPIC SINUS

SURGERY. PROCEEDINGS OF SINGAPORE HEALTHCARE, 2014;VOLUME

23:NO 3: 246-253

They concluded that Functional endoscopic sinus surgery is a widely accepted

and increasingly popular procedure that is acceptable to patients who have medically

refractory rhino-sinusitits and enjoys a high success rate. For the anaesthetist, it

provides an interesting challenge to use the latest drugs and techniques available in

order to allow an optimal operating field while decreasing the risk of surgery and

improve patient safety and satisfaction.

39

15. G Guler, A Akin, E Tosun, E Eskitafloglu, A Mizrak, A Boyaci.

SINGLE DOSE DEXMEDETOMIDINE ATTENUATES AIRWAY AND

CIRCULATORY REFLEXES DURING EXTUBATION. ACTA ANAESTHESIOL

SCAND. 2005;49:1088–91.

They conducted the study in 60 patients and concluded that a single dose bolus

injection of Dexmedetomidine before tracheal extubation attenuates airway circulatory

reflexes during extubation

40

MATERIAL AND METHODS

This was a prospective, randomised study of 40 patients, with ASA physical

status ASA PS I-II, between 18-65 years of age, BMI < 35, planned for elective

functional endoscopic sinus surgery between April 2018 and September 2018. The

study was approved by the institute’s Ethical committee and informed consent was

obtained from the patients. Patients not willing for the study, with renal and hepatic

impairment, bleeding and coagulation disorders, history of allergy, those receiving

calcium channel blockers and receiving agents contraindicated for controlled

hypotension have been excluded from the study. Patients were allocated to two groups

(Group D and Group M) by random selection.

After arriving in the operating room, patients were connected to ASA standard

monitors (NIBP, ECG, spO2, ETCO2 and Temperature). Baseline MAP and Heart

rate were recorded. Monitoring was done every five minutes, with MAP and Heart

rate being recorded post induction, post intubation, at minutes 5, 10, 15, 30 and 45,

post extubation and 5 minutes post extubation. An intravenous line was secured and

intravenous fluids given according to Holliday Segar formula [23]. Patients received

supplemental oxygen, Inj. Glycopyrrolate 0.2mg and Inj. Midazolam 1mg

intravenously. Patients in Group M received a loading dose of 40mg/kg of magnesium

sulfate in 100ml NS 10 minutes before induction of anaesthesia. Patients in Group D

received a loading dose of 1µg/kg of Dexmedetomidine in 100 ml NS 10 minutes

before induction of anaesthesia.

After adequate preoxygenation, Inj Fentanyl 2µg/kg given for attenuation of

hemodynamic response to intubation and intraoperative analgesia. Induction of

41

anaesthesia was achieved by Inj. Thiopentone 3-5 mg/kg titrated till loss of eyelash

reflex. Inj. Atracurium 0.5 mg/kg given for achieving muscle paralysis. Intubation

done using appropriate size endotracheal tube and throat packing done. Nasal mucosa

infiltrated with 2 ml 2% lignocaine with 1:200000 Adrenaline 5 minutes before

incision. Anaesthesia maintained with Sevoflurane in oxygen-nitrous oxide mixture

and Inj. Atracurium 0.1 mg/kg. Total dose of Inj. Atracurium used during the surgery

noted. Volume controlled mechanical ventilation done with target ETCO2 of 35-40

mmHg. Skin temperature maintained above 32ºC.

Maintenance dose of magnesium sulfate 10-15mg/kg in Group M and

Dexmedetomidine 0.5-1 µg/kg in Group D started and titrated to achieve controlled

hypotension. Controlled hypotension was defined as MAP decrease of 20% - 30%

from baseline MAP. The target MAP between 20% - 30% was decided after revising

previous studies in which hypotension was induced to provide bloodless field and

studies regarding the hazard of tissue ischemia with induced hypotension [11,15,31].

Time taken to achieve 20% decrease in baseline MAP recorded. If 20% decrease is

not achieved within 15 minutes after maximum limit of maintenance dose, Inj.

Nitroglycerine infusion started and titrated to achieve required decrease in MAP. If

decrease in MAP was more than 30% despite minimum limit of maintenance dose,

Inj. Ephedrine 6 mg was given. Bradycardia was defined as fall in heart rate less than

20% of baseline or heart rate 50 beats/minute, whichever is lower and atropine 0.6 mg

administered in patients who developed bradycardia.

42

Infusion of Magnesium sulfate and Dexmedetomidine stopped at the end of

surgery. Inj. Ondansetron 0.1 mg/kg given 30 minutes before extubation. Inj.

Neostigmine (50 µg/kg) and Inj. Glycopyrrolate (10 µg/kg) were given to reverse the

effects of Inj. Atracurium after adequate spontaneous recovery of neuromuscular

blockade. Patients’ level of sedation post extubation was assessed using Modified

Ramsay sedation scale.

SCORE CHARACTERISTICS

1 Awake and alert, minimal or no cognitive impairment

2 Awake but tranquil, purposeful responses to verbal commands at

conversational level

3 Appears asleep, purposeful responses to verbal commands at

conversational level

4 Appears asleep, purposeful responses to verbal commands but at

louder than conversational level or light glabellar tap

5 Asleep, sluggish purposeful responses only to loud verbal

commands or strong glabellar tap

6 Asleep, sluggish purposeful response only to painful stimuli

7 Asleep, reflex withdrawal to painful stimuli only

8 Unresponsive to external stimuli, including pain

43

2-3 Minimal sedation

4-5 Moderate sedation

6-8 Deep sedation

Occurrence of shivering or otherwise was duly noted. Patients with modified

Aldrete score ≥ 9 [4] were transferred to the ward. Duration of surgery is noted as

time taken from loading dose of agent to extubation of patient.

Surgical site visibility was evaluated by the surgeon and communicated to by

the same. Evaluation was based on 6 point scale. [6,10,18]

0 – No bleeding

1 – Mild bleeding, suction not necessary

2 – Mild bleeding, occasional suctioning required, non threatened surgical field

3 – Mild bleeding, frequent suctioning required, bleeding threatens surgical field few

seconds after suction

4 – Moderate bleeding, frequent suctioning required, bleeding threatens surgical site

immediately after suction

5 – Severe bleeding, continued suction needed, bleeding appears faster than it can be

removed by suction

The degree of satisfaction of the surgeon was evaluated by a 4 points scale [6],

1 – little, 2 – moderate, 3 – good, 4- very good

44

STATISTICAL ANALYSIS

Data collected was entered in Microsoft Excel 2013. The collected data were

analysed with IBM.SPSS statistics software 23.0 Version.

To describe about the data descriptive statistics, frequency analysis and

percentage analysis were used for categorical variables and the mean & S.D

were used for continuous variables.

To find the significant difference between the bivariate samples in independent

groups, unpaired sample t-test was used.

To find the significance in categorical data, Chi-Square test was used.

Similarly if the expected cell frequency is less than 5 in 2×2 tables then Fisher's

exact test was used.

In all the above statistical tools the probability value of 0.05 is considered as

significant level.

45

OBSERVATION AND RESULTS

Table 1: Comparison of Age distribution among both groups

Groups

Total

2 -

value

P-value

Group D Group M

Age

21 - 30

yrs

Count 6 3 9

2.2095 0.53

% 30.0% 15.0% 22.5%

31 - 40

yrs

Count 8 7 15

% 40.0% 35.0% 37.5%

41 - 50

yrs

Count 3 6 9

% 15.0% 30.0% 22.5%

Above

50 yrs

Count 3 4 7

% 15.0% 20.0% 17.5%

Total

Count 20 20 20

% 100.0% 100.0% 100.0%

Difference in Age distribution in both groups was not statistically significant.

Hence age distribution in both groups was comparable.

46

Fig 1: Comparison of Age distribution among both groups

Table 2. Comparison of the study groups according to mean age

Groups N Mean S.D t-test P-value

Age

Group D 20 37 10

1.6670 0.1037

Group M 20 43 10

The difference in the mean age between the study groups was not statistically

significant. Hence the groups are comparable with regards to mean age.

0

1

2

3

4

5

6

7

8

9

21 - 30 yrs 31 - 40 yrs 41 - 50 yrs Above 50 yrs

Age distribution

Group D Group M

47

Fig 2: Comparison of mean age among both groups

0

5

10

15

20

25

30

35

40

45

50

Group D Group M

Me

an

Groups

Age

48

Table 3: Comparison of gender distribution among both groups

Groups

Total

2 -

value

P-value

Group D Group M

Sex

Female

Count 9 10 19

0.100 0.7515

% 45.0% 50.0% 47.5%

Male

Count 11 10 21

% 55.0% 50.0% 52.5%

Total

Count 20 20 20

% 100.0% 100.0% 100.0%

Difference in Gender distribution among the groups was not statistically

significant. Hence the gender distribution in both the groups was comparable.

49

Fig 3: Comparison of Gender distribution among both groups

0

2

4

6

8

10

12

Group D Group M

Gender distribution

Female Male

50

Table 4: Comparison of weight among both groups

Groups N Mean S.D t-test

P-

value

Weight

Group

D

20 58.0 11.6

1.0313 0.3089

Group

M

20 61.8 11.7

Comparison of mean weight among the groups was not statistically significant.

Hence weight distribution among both groups was comparable.

Fig 4: Comparison of weight among both groups

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

Group D Group M

Me

an

Groups

Weight

51

Table 5: Comparison of ASA physical status among Groups

Groups

Total 2 - value P-value

Group D Group M

ASA PS

I

Count 16 16 32

0.000 1.000

% 80.0% 80.0% 80.0%

II

Count 4 4 8

% 20.0% 20.0% 20.0%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

Comparison of distribution of ASA physical status among the groups was not

statistically significant. Hence the groups were comparable in regards to ASA

Physical status.

52

Fig 5: Comparison of ASA Physical status among both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

ASA Physical status

I II

53

Table 6: Comparison of Duration of surgery among both groups

Groups N Mean S.D t-test

P-

value

Duration

Group

D

20 143 38

0.2180 0.828

Group

M

20 141 27

Comparison of mean duration of surgery among the groups was not statistically

significant. Hence duration of surgery was comparable in both groups and not

prolonged in either group.

Fig 6: Comparison of duration of surgery among both groups

0

20

40

60

80

100

120

140

160

Group D Group M

Me

an

Groups

Duration

54

Table 7: Comparison of MAP among both groups

Groups N Mean S.D t-test P-value

Baseline

Group D 20 99.3 8.3

0.4860 0.629

Group M 20 100.9 11.6

Post Induction

Group D 20 83.5 16.4

0.7370 0.467

Group M 20 86.7 9.8

Post Intubation

Group D 20 103.3 12.7

4.1550 0.0005

Group M 20 118.2 9.8

5 Mins

Group D 20 85.8 12.6

1.2170 0.231

Group M 20 90.2 10.1

10 Mins

Group D 20 80.1 9.3

1.1680 0.250

Group M 20 83.3 8.0

15 Mins

Group D 20 77.2 9.4

0.6960 0.491

Group M 20 79.2 9.2

30 Mins

Group D 20 74.3 6.7

0.7840 0.438

Group M 20 76.0 7.0

45 Mins

Group D 20 74.2 6.4

0.6100 0.546

Group M 20 75.6 7.5

Post Extubation

Group D 20 99.7 8.0

2.8330 0.007

Group M 20 109.3 12.9

Post Extubation 5 Mins

Group D 20 92.8 6.9

1.7370 0.090

Group M 20 98.2 11.9

55

Difference in baseline MAP was not statistically significant. Hence the groups

were comparable with regards to Baseline MAP.

Difference in MAP during the Post intubation period and Post extubation

period was statistically significant. Hence Group D had less increase of MAP

compared to Group M post intubation and post extubation.

Differences in MAP during post induction, 5 minutes, 10 minutes, 15 minutes,

30 minutes and 45 minutes post intubation and 5 minutes post extubation were not

statistically significant. Both groups were comparable with regards to MAP during

post induction, intraoperative period and 5minutes post extubation.

Fig 7 Comparison of MAP among groups

020406080

100120140

Me

an

Groups

MAP

Group D Group M

56

Table 8: Comparison of Heart rate among both groups

Groups N Mean Std.

Deviation t-test P-value

Baseline

Group D 20 86.7 18.3

0.0660 0.948

Group M 20 87.0 15.1

Post Induction

Group D 20 85.0 15.7

1.0670 0.293

Group M 20 89.7 11.9

Post intubation

Group D 20 95.7 12.5

2.3301 0.025 Group M 20 103.6 8.8

5 Mins

Group D 20 86.4 14.2

0.0360 0.972 Group M 20 86.6 12.4

10 Mins Group D 20 83.2 14.8

0.2380 0.813

Group M 20 82.2 10.0

15 Mins

Group D 20 78.5 13.7

0.3020 0.764

Group M 20 79.7 11.3

30 Mins

Group D 20 78.3 10.8

0.1780 0.860

Group M 20 77.7 10.5

45 Mins

Group D 20 74.1 9.5

0.6060 0.548 Group M 20 75.9 9.8

Post Extubation

Group D 20 88.5 11.1

2.8720 0.007 Group M 20 98.4 10.8

Post Extubation 5

Mins

Group D 20 78.6 11.3 3.3430 0.002

Group M 20 89.6 9.3

57

Difference in baseline Heart rate was not statistically significant. Hence

the groups were comparable with regards to Baseline MAP.

Differences in Heart rate during the Post intubation period, Post extubation

period and 5 minutes post extubation were statistically significant. Hence Group D

had less increase of Heart rate compared to Group M post intubation, post extubation

and 5 minutes post extubation.

Differences in heart rate during post induction, 5 minutes, 10 minutes, 15

minutes, 30 minutes and 45 minutes post intubation were not statistically significant.

Both groups were comparable with regards to heart rate during post induction and the

intraoperative period.

Fig 8. Comparison of heart rate among groups

0

20

40

60

80

100

120

Me

an

Groups

Heart Rate

Group D Group M

58

Table 9: Comparison of bleeding scores among both groups

Bleeding score

Groups

Total

2 -

value

P-value

Group D Group M

I

Count 11 3 14

7.1048 0.0287

% 55.0% 15.0% 35.0%

2

Count 7 14 21

% 35.0% 70.0% 52.5%

3

Count 2 3 5

% 10.0% 15.0% 12.5%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

Difference in bleeding scores of both groups was statistically significant.

Group D had lower bleeding scores when compared with Group M.

59

Fig 9: Comparison of bleeding scores among both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Groups

Bleeding Score

1 2 3

60

Table 10: Comparison of Surgeon satisfaction among both groups

Surgeon Satisfaction

Groups

Total

2 -

value

P-value

Group D Group M

2

Count 4 6 10

7.2214 0.027

% 20.0% 30.0% 25.0%

3

Count 5 11 16

% 25.0% 55.0% 40.0%

4

Count 11 3 14

% 55.0% 15.0% 35.0%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

The difference in surgeon satisfaction among both the groups was statistically

significant. Group D had higher surgeon satisfaction score than Group M.

61

Fig 10: Comparison of Surgeon satisfaction among both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Surgeon Satisfaction with Groups

2 3 4

62

Table 11: Comparison of time taken to achieve 20% decrease in MAP

Time to achieve 20% decrease Group D

Group

M

Total

2 -

value

P-value

0-5mins

Count 4 2 6

2.628 0.453

% 20.0% 10.0% 15.0%

5-10mins

Count 7 4 11

% 35.0% 20.0% 27.5%

10-15mins

Count 6 10 16

% 30.0% 50.0% 40.0%

>15mins

Count 3 4 7

% 15.0% 20.0% 17.5%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

The difference in time taken to achieve 20% decrease in MAP is not

statistically significant. Time taken to achieve 20% decrease in MAP was comparable

in both groups.

63

Fig 11: Comparison of time taken to achieve 20% decrease in MAP

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Groups

Time to Achieve 20% Decrease in MAP

0-5mins 5-10mins 10-15mins >15mins

64

Table 12: Comparison of need for NTG in both groups

Need for NTG

Groups

Total

2 -

value

P-value

Group D

Group

M

No

Count 17 16 33

0.173 1.000 #

% 85.0% 80.0% 82.5%

Yes

Count 3 4 7

% 15.0% 20.0% 17.5%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

There was no statistically significant difference in need for NTG among the

two groups. Need for NTG was comparable in both groups.

65

Fig 12: Comparison of need for NTG in both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Groups

Need for NTG

No Yes

66

Table 13: Comparison of Atracurium need among both groups

Groups N Mean S.D t-test P-value

Atracurium dose

Group D 20 52.8 11.4

2.2710 0.029

Group M 20 45.0 10.1

There was statistical significance in Atracurium need among both groups.

Group M had statistically significant decrease in Atracurium need compared to Group

D.

Fig 13: Comparison of Atracurium need among both groups

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

40.0

45.0

50.0

55.0

60.0

Group D Group M

Me

an

Atracurium dose

67

Table 14: Comparison of postoperative sedation among both groups

Modified Ramsay

sedation scale

Groups

Total

2 -

value

P-value

Group D Group M

2

Count 9 13 22

2.327 0.507

% 45.0% 65.0% 55.0%

3

Count 9 6 15

% 45.0% 30.0% 37.5%

4

Count 1 1 2

% 5.0% 5.0% 5.0%

5

Count 1 0 1

% 5.0% 0.0% 2.5%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

The differences in the modified Ramsay sedation scale among the two groups

were not statistically significant. Postoperative sedation was comparable in both

groups.

68

Fig 14: Comparison of postoperative sedation among both groups

0

2

4

6

8

10

12

14

2 3 4 5

Modified Ramsay sedation scale

Group D Group M

69

Table 15: Comparison of bradycardia among both groups

Bradycardia

Groups

Total

2 -

value

P-value

Group D Group M

No

Count 17 20 37

3.243 0.231

% 85.0% 100.0% 92.5%

Yes

Count 3 0 3

% 15.0% 0.0% 7.5%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

The difference in incidence of bradycardia in both groups was not statistically

significant. The incidence of bradycardia is comparable in both groups.

70

Fig 15: Comparison of bradycardia among both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Groups

Bradycardia with Groups

No Yes

71

Table 16: Comparison of hypotension among both groups

Hypotension

Groups

Total

2 -

value

P-value

Group D Group M

No

Count 18 20 38

2.105 0.487 #

% 90.0% 100.0% 95.0%

Yes

Count 2 0 2

% 10.0% 0.0% 5.0%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

The difference in the incidence of hypotension in both groups was not

statistically significant. The incidence of hypotension in both groups was comparable

72

Fig 16: Comparison of hypotension among both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Groups

Hypotension with Groups

No Yes

73

Table 17: Comparison of shivering among both groups

Shivering

Groups

Total

2 -

value

P-value

Group D Group M

No

Count 19 19 38

0.000 1.000#

% 95.0% 95.0% 95.0%

Yes

Count 1 1 2

% 5.0% 5.0% 5.0%

Total

Count 20 20 40

% 100.0% 100.0% 100.0%

The difference in incidence of shivering among both groups was not

statistically significant. The incidence of shivering was comparable in both groups.

74

Table 17: Comparison of shivering among both groups

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Group D Group M

Pe

rce

nta

ge

Groups

Shivering with Groups

No Yes

75

SUMMARY

In our study conducted to compare Dexmedetomidine and magnesium sulfate

in controlled hypotension during functional endoscopic sinus surgery, the following

observations were statistically significant

1. Patients in Group D had statistically significant less increase of MAP compared

to those in Group M post intubation (103.3 vs. 118.2) and post extubation (99.7

vs. 109.3).

2. Patients in Group D had statistically significant less increase of Heart rate

compared to those in Group M post intubation (95.65 vs. 103.6), post

extubation (88.5 vs. 98.4) and 5 minutes post extubation (78.6 vs. 89.6).

3. Patients in Group D had lower bleeding scores when compared with those in

Group M.

4. Patients in Group D had higher surgeon satisfaction scores when compared

with those in Group M

5. Patients in Group M had statistically significant lesser need for Atracurium

intraoperatively when compared with those in Group D (45 vs. 52.8)

76

DISCUSSION

FESS is an endoscopic surgical procedure which requires an endoscope to do

all necessary manipulations. During the procedure, even small amount of bleeding

will reduce visibility, hence bleeding must be minimised. Various approaches have

been used. Here, we compare dexmedetomidine and magnesium sulfate in providing

controlled hypotension to minimise bleeding.

In our study, no significant difference was found in terms of age, weight,

gender, physical status. This study revealed that dexmedetomidine was better in

performing controlled hypotension during Functional endoscopic sinus surgery

compared to magnesium sulfate by proving that it provided better surgical site

visibility and surgeon satisfaction, as observed by Adnan Bayram et al [6] and Ackan

Akkaya [3]. The necessity of nitroglycerine was not less, in patients receiving

Dexmedetomidine when compared with patients receiving magnesium sulfate, though,

as observed by Adnan Bayram et al [6].

In our study, there was no significant difference in duration of surgery, similar

to Akkaya et al [3], Aboushanab et al [1] and Modir et al [28]. The difference in time

taken to achieve the desired MAP was not statistically significant among both groups,

unlike the observation made by Omyma S.M. Khalifa et al [26]. There was significant

difference in total dose of atracurium required with patients in Group M requiring

lesser dose than those in Group D. This was dissimilar to the observation by Rabie

Solimon et al [33].

77

When comparing the intraoperative MAP and heart rate, there was no statistical

difference in the baseline values, indicating that the two groups were comparable. The

intraoperative values were also not significantly different except the post intubation

and post extubation periods, signifying that Dexmedetomidine attenuated the

hemodynamic stress response to tracheal intubation and extubation better than

magnesium sulfate.

Comparison of postoperative sedation scores was not statistically significant,

unlike results in other studies [1,26,28]. There was no significant difference in the

incidence of bradycardia and hypotension unlike the observations made by Rabie

Solimon et al [33]

We did not include a control group in the study as the surgeons requested

deliberate hypotension for all patients.

78

CONCLUSION

We conclude that Dexmedetomidine when used in the doses mentioned in this

study provided controlled hypotension in a more effective manner than magnesium

sulfate in patients undergoing functional endoscopic sinus surgery, by providing

increased surgical site visibility and surgeon satisfaction, while also having the added

advantage of better attenuation of hemodynamic stress response to tracheal intubation

and extubation, without prolonged recovery period or increased risk of complications.

Therefore, we recommend the use of Dexmedetomidine as a safe agent to produce

controlled hypotension to minimise bleeding in patients undergoing FESS.

79

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A Relationship between intraoperative hypotension, defined by either

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induced postoperative hyperalgesia in patients undergoing thyroidectomy.

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35. Yuen VM, TW Hui, MG Irwin, MK Yuen. A comparison of intranasal

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7

ANNEXURE

8

9

PLAGIARISM CERTIFICATE

This is to certify that this dissertation work titled COMPARISON

BETWEEN MAGNESIUM SULFATE AND DEXMEDETOMIDINE IN

CONTROLLED HYPOTENSION DURING FUNCTIONAL ENDOSCOPIC

SINUS SURGERY of the candidate Dr. Sriram Sundar. M with registration

number 201720016 for the award of MD degree in the branch of Anaesthesiology. I

personally verified the urkund.com website for the purpose of plagiarism check. I

found that the uploaded thesis file contains from introduction to conclusion pages and

result shows 14 % percentage of plagiarism in the dissertation.

Guide & Supervisor

DR. Vellingiri. M, M.D., D.A.,

Professor,

Institute of Anaesthesiology and Critical Care,

Madras Medical College

Chennai.

10

11

12

13

14

INFORMATION TO PARTICIPANTS

Investigator : Dr. Sriram Sundar. M

Name of the Participant:

Title : “COMPARISON BETWEEN MAGNESIUM SULFATE AND

DEXMEDETOMIDINE IN CONTROLLED HYPOTENSION DURING

FUNCTIONAL ENDOSCOPIC SINUS SURGERY"

You are invited to take part in this research study. We have got approval from the

IEC. You are asked to participate because you satisfy the eligibility criteria. We want

to compare and study the efficacy of MAGNESIUM SULFATE AND

DEXMEDETOMIDINE in producing controlled hypotension to minimise bleeding

during Functional endoscopic sinus surgery.

What is the Purpose of the Research:

To compare

1. Blood loss by surgical site visibility

2. Satisfaction of surgeon

3. Time taken to achieve desired mean arterial pressure

4. Total need of muscle relaxants

5. Attenuation of hemodynamic response to intubation and extubation

6. Postoperative sedation

7. Adverse effects

15

The Study Design:

All the patients in the study will be divided into two groups.

Group D – Dexmedetomidine 1 µg/kg in 100ml loading dose over 10 minutes

followed by 0.5-1 µg/kg/min maintenance

Group M – Magnesium sulfate 40mg/kg in 100 ml loading dose over 10 minutes

followed by 10-15 mg/kg/hr maintenance

All patients will be given general anaesthesia.

Benefits

Dexmedetomidine and Magnesium sulfate decrease blood loss thereby

reducing the chances of hypotension and need for blood transfusion, improve surgical

site visibility thereby decreasing the duration of surgery and associated complications.

Discomforts and risks

Hypotension

Bradycardia

Sedation

16

This intervention has been shown to be well tolerated as shown by previous

studies. And if you do not want to participate you will have alternative of setting the

standard treatment and your safety is our prime concern.

Time:

Date: Signature / Thumb Impression of Patient

Place: Patient Name:

Signature of the Investigator : ____________________________

Name of the Investigator : ____________________________

MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR

1 26 M 70 I 190 96 91 73 103 112 105 86 100 89 91 77 73 77 72 77 70

2 32 F 59 I 155 99 72 97 73 101 70 88 77 81 75 72 71 72 78 75 79

3 55 M 74 I 90 106 65 71 99 101 107 95 69 84 68 83 69 79 70 71 69

4 50 M 72 I 140 101 91 95 98 107 92 86 92 79 91 82 85 79 80 77 79

5 21 F 55 I 150 100 113 55 85 88 104 62 93 67 90 62 87 80 89 79 84

6 55 M 62 I 235 95 61 94 57 81 80 84 81 73 57 75 53 73 59 76 60

7 40 M 62 II 100 112 84 79 82 94 101 72 82 66 76 68 79 57 71 65 66

8 26 F 40 I 135 92 71 84 78 121 99 127 97 108 107 102 103 71 89 68 67

9 32 F 60 II 100 90 64 70 65 91 78 93 50 81 57 61 58 63 60 66 63

10 53 M 55 I 125 85 59 63 60 86 91 84 70 70 63 78 55 68 66 68 56

11 38 F 40 II 185 115 102 94 110 110 116 86 96 80 93 75 80 76 85 79 84

12 28 F 37 I 200 93 94 93 100 135 100 76 110 79 96 84 86 75 85 75 84

13 27 F 59 II 160 105 87 104 86 94 91 88 95 81 84 84 83 85 80 83 79

14 48 M 73 I 150 98 96 73 75 107 100 86 88 77 87 78 86 75 79 73 76

15 28 F 50 I 155 108 98 109 100 98 81 95 81 93 77 90 75 85 92 87 75

16 37 M 69 I 125 91 103 72 87 108 104 77 90 76 89 76 81 73 82 72 77

17 32 M 58 I 105 89 77 96 75 111 86 76 78 75 77 70 75 71 73 71 71

18 37 F 40 I 135 101 129 53 109 110 118 80 110 78 113 68 108 71 103 62 96

19 37 M 57 I 110 99 95 97 85 100 99 84 89 79 90 77 83 75 80 80 78

20 41 M 67 I 115 111 81 98 73 111 91 90 80 85 82 81 79 80 72 80 68

30 mins 45 mins

GROUP-D

10 mins 15 mins

S.No Age Sex Weight ASA PS

Baseline Post Post 5 mins

Duration

MAP HR MAP HR

93 91 91 84 10-15mins 3 2 no 3 70 no no no

105 87 95 67 10-15mins 2 3 no 3 50 no no yes

97 82 89 74 5-10mins 2 4 no 3 50 no no no

98 91 90 88 5-10mins 2 4 no 2 55 no no no

103 103 97 89 0-5 1 4 no 2 50 no no no

109 75 96 72 5-10mins 2 4 no 4 40 no no no

77 86 89 85 0-5 1 4 no 2 55 no yes no

95 75 93 73 >15mins 3 2 yes 2 45 yes no no

104 89 95 62 10-15mins 1 3 no 2 50 yes yes no

88 88 81 61 >15mins 2 2 yes 2 35 no no no

103 80 80 69 0-5 1 4 no 3 35 no no no

112 69 105 70 >15mins 1 4 yes 5 55 no no no

102 83 100 79 5-10mins 2 4 no 2 50 no no no

99 88 91 79 5-10mins 1 4 no 3 70 no no no

110 115 106 101 10-15mins 1 3 no 3 55 yes no no

104 95 100 76 10-15mins 2 2 no 3 50 no no no

100 83 90 75 10-15mins 1 3 no 3 55 no no no

93 110 84 104 0-5 1 4 no 2 40 no no no

100 90 91 83 5-10mins 1 4 no 2 70 no no no

101 89 93 81 5-10mins 1 3 no 3 75 no no no

Shivering

Atracurium

dose

Post 5 mins Bleeding

score

Surgeon

Satisfaction

Need for

NTG

Modified ramsay

sedation score

Time to

achieve 20%

Brady

cardia

Hypo

tension

MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR MAP HR

1 28 M 58 I 185 100 103 79 93 108 108 87 103 88 88 92 82 72 76 80 70 103 101

2 58 F 51 I 140 101 77 92 83 130 90 91 85 85 87 75 85 77 83 76 77 104 100

3 55 M 52 I 170 98 64 88 82 102 102 89 89 88 90 87 92 78 84 79 84 110 106

4 57 F 57 I 120 90 81 79 75 116 92 81 83 79 77 72 76 71 75 72 74 98 103

5 30 M 62 I 160 97 96 89 97 126 118 110 110 85 95 76 101 77 92 78 89 119 116

6 32 F 49 I 145 90 100 78 111 108 109 80 90 68 82 67 75 69 75 68 80 110 98

7 55 M 65 I 145 126 83 101 81 127 101 113 71 103 72 102 70 88 66 87 59 132 100

8 50 F 45 II 105 106 103 91 101 133 110 101 102 82 99 85 100 73 100 74 91 106 125

9 49 M 70 II 105 99 126 91 111 117 114 72 100 68 100 73 98 73 97 79 92 120 106

10 38 F 55 I 140 75 94 68 98 112 112 96 83 80 84 68 71 57 74 52 71 95 99

11 50 M 60 II 105 121 66 77 70 123 99 83 58 83 63 85 64 83 64 79 62 131 77

12 40 M 61 II 135 110 66 82 70 122 95 91 74 86 71 84 68 80 66 72 65 85 87

13 37 F 55 I 120 111 91 100 96 132 100 92 92 82 87 80 86 79 85 78 88 118 95

14 32 M 90 I 190 105 92 102 100 120 105 89 74 86 69 80 68 83 68 81 69 96 90

15 48 F 62 I 125 89 82 80 87 111 94 79 81 73 78 69 76 71 77 70 79 108 97

16 44 M 55 I 155 100 92 77 85 114 113 95 90 91 85 88 81 79 77 80 77 103 85

17 38 F 83 I 115 109 79 101 91 131 101 89 93 82 86 78 85 81 86 80 80 107 92

18 29 M 68 I 125 105 84 95 86 121 114 98 89 92 71 83 67 85 64 85 63 133 90

19 35 F 81 I 150 93 71 83 80 109 88 83 75 81 79 68 74 70 73 69 77 107 106

20 45 F 56 I 180 92 90 80 97 102 107 84 89 83 81 72 74 73 71 72 71 100 95

15 minsBaseline Post Post 5 mins 10 mins 30 mins 45 mins Post

GROUP M

S.No Sex Weight ASA PS DurationAge

MAP HR

100 95 >15mins 2 2 yes 2 35 no no no

97 91 10-15mins 2 3 no 3 35 no no no

101 95 >15mins 3 2 yes 2 50 no no no

89 94 10-15mins 2 3 no 2 40 no no no

100 101 10-15mins 2 2 no 2 40 no no no

106 89 10-15mins 2 2 no 2 35 no no no

127 94 10-15mins 2 3 no 2 40 no no no

78 89 5-10mins 1 3 no 2 40 no no no

117 117 0-5mins 2 4 no 2 60 no no no

78 87 >15mins 2 2 yes 3 35 no no no

114 81 0-5mins 2 4 no 2 35 no no no

83 80 5-10mins 2 4 no 3 40 no no yes

98 86 5-10mins 2 3 no 2 45 no no no

94 84 10-15mins 3 3 no 4 70 no no no

101 88 10-15mins 2 3 no 2 45 no no no

95 81 >15mins 2 2 yes 2 40 no no no

98 83 5-10mins 2 3 no 2 55 no no no

98 74 10-15mins 1 3 no 3 55 no no no

95 97 10-15mins 1 3 no 3 60 no no no

94 85 10-15mins 3 3 no 3 45 no no no

5 mins Time to

achieve 20%

Brady

cardia

Hypo

tension

Shiverin

g

Surgeon

Satisfaction

Need for

NTG

Modified Ramsay

sedation score

Atracurium

dose

Bleeding

score