The PONV Problem - SCOAP: Surgical Clinical Outcomes ... · Lau H & Brooks DC. Arch Surg ... Gan...
Transcript of The PONV Problem - SCOAP: Surgical Clinical Outcomes ... · Lau H & Brooks DC. Arch Surg ... Gan...
The PONV Problem
John B Leslie, MD MBA
The PONV Problem:Frequent – Predictable – Evaluable –Expensive – Dissatisfying – Avoidable
John B. Leslie, MD, MBAProfessor
Department of AnesthesiologyMayo Clinic College of Medicine
Rochester, MinnesotaConsultant in Anesthesiology
Mayo Clinic Arizona, Scottsdale, AZProfessor of Clinical Anesthesia
University of Arizona, Tucson, AZ
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PONV “Terminology”• Air the diced carrots• Barf - Boot - Blow - Brack• Bark at the moon• Blow foam, chunks, or bile• Bring it up for a vote• Burpin’ solid• Call Uncle Earl or Ralph• Call Europe• Call on great white telephone• Call up the beasties• Chumming• Chunder and Chunks• Clean house• Core dump• Drive the porcelain bus• Drive the Buick• Emit with a food fountain• Empty your bucket
• Fertilize the carpet• Growl at the ground• Hurl - Hack - Heave - Huey• Liquid laugh or yawn• Lunch re-run• Laugh at the carpet• Make an inventory• Make a pavement pizza• Private exorcism (AKA LB)• Produce the liquid laugh• Puke - Spew - Retch - Urp• Park the tiger• Protein spill• Shout at your shoes• Sick-up and spew• Technicolor yawn• Toss your cookies• Vomit or Un-eat
Have we solved the PONV “little big problem” ?
3 decades of clinical trialsRisk Stratification
Multiple combination therapiesGuidelines & Updated Guidelines
“Breakthrough medications”“Break-the-Bank Expenses”
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Gan TJ, et al Guidelines for the Management of PONV; Anesth Anal, Vol 105, December, 2007. Kovac. Drugs. 2000;59:213-243; Natof et al. In: Wetchler, ed. Anesthesia for Ambulatory Surgery. 2nd ed. 1991:437-474; Carroll et al. Anesth Analg. 1995;80:903-909; Gan et al. Anesth Analg. 2002;94:1199-2000; Gan. JAMA. 2002;287:1233-1236; Leslie and Bash. Poster presented at: NYSSA 57th Postgraduate Assembly; December 13, 2003; New York, NY; Gan et al. Anesth Analg. 2003;97:62-71; Chung et al. Eur J Anaesthesiol. 1999;16:669-677; Hirayama et al. Yakugaku Zasshi. 2001;121:179-185.
Incidence of PONV/PDNV/OIE
• Overall range: 25% to 30%• High-risk patients: 70% to 80%• Outpatient range: 20% to 80%, depending on the patient
population• 35% to 67% of patients may experience PDNV• PONV may persist for 5 days after surgery• Opioid-induced emesis (OIE): 10% to 60%• No 1 or No 2 adverse outcome following routine
outpatient surgery!
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Many Patients Experience PONV Beyond the PACU
• Overall: 41% had PONV and … of patients who experienced PONV, nearly 80% initially did so in the PACU and/or within 48 hours after discharge.
36%
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Initial PONVin the PACU
(21/58)
Initial PONV in the PACU and/or Within 48 Hours After PACU Discharge
(45/58)
Study Design: Data from a study examining patients’ experiences with PONV following discharge from outpatient surgery centers. Incidence of PONV was measured in the recovery room, by telephone the day after discharge, and by a questionnaire that patients were instructed to complete 5 days after discharge. A total of 143 outpatients (aged ≥18 years) who received general anesthesia and underwent 1 of 4 selected surgeries (laparoscopy, dilation and curettage, arthroscopy, or hernia repair) provided complete data. Some patients who initially experienced PONV within 48 hours after PACU discharge continued to experience PONV for up to 5 days after PACU discharge.
Carroll NV et al. Anesth Analg. 1995;80:903–909.
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The PONV Problem
John B Leslie, MD MBA
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PONV Remains a Problem Despite Current Therapies
Overall Up to 30% for all surgeries and patient populations.1–3
OutpatientAbout 40% of patients with PONV treated at outpatient surgery centers.4
Breakthrough
More than 30% of patients with PONV were receiving prophylactic antiemetics.3
— No significant differences among ondansetron, dexamethasone, and droperidol
1. Kovac AL. Drugs. 2000;59:213–243.2. Habib AS, Gan TJ. Can J Anesth. 2004;51:326–341.3. Apfel CC et al. N Engl J Med. 2004;350:2441–2451.4. Carroll NV et al. Anesth Analg. 1995;80:903–909.
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The Real Value of Guidelines?
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PONV vs PDNV: Under-Recognized Problem
C Apfel, S Shi, A Kovac, A Shilling, J Leslie, B Philip, on behalf of the PDNV Study Group: IARS Annual Mtg. 2009
Prospective Study of 2170 Outpatients in 12 USA Centers
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PONV vs PDNV: Under-Recognized Problem
C Apfel, S Shi, A Kovac, A Shilling, J Leslie, B Philip, on behalf of the PDNV Study Group: IARS Annual Mtg. 2009
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PONV vs PDNV: Under-Recognized Problem
C Apfel, S Shi, A Kovac, A Shilling, J Leslie, B Philip, on behalf of the PDNV Study Group: IARS Annual Mtg. 2009
Conclusion: The results of this 12-center multicenter cohort study showed a substantial incidence of PDNV in the US.…Clinical trials that address this patient population with a longacting antiemetic strategy are needed
What does failure to prevent PONV actually cost?
Patient Risk
Patient discomfort
Patient dissatisfaction
Economic burden
The PONV Problem
John B Leslie, MD MBA
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Potential Consequences of PONV
• Medical Consequences PONV— Can cause electrolyte abnormalities and dehydration1
— Can cause tension on suture lines1,2
— Venous hypertension2
— Can cause hematomas (increased bleeding) beneath surgical flaps,1 vascular anastomosis, aneurysm clipping, etc
— Can place the patient at risk for pulmonary aspiration of vomit if airway reflexes are depressed from lingering effects of anesthetic and analgesic drugs1,2 (esp increased risk with jaw wired closed)
• Practical Consequences of PONV— Delayed Discharge after out-patient surgery2
— Unanticipated hospital admission1
1. Golembiewski J, et al Am J Health-Sys Pharm; Vol 62 Jun, 2005 2. Watcha MF, White PF. Anesthesiology. 1992;77:162–184.
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PONV: #1 Patient Problem
Recall without pain5Residual weakness6Shivering7Sore throat8Somnolence9
Incisional pain3Gagging on endotracheal tube2
Nausea4
Vomiting1Postoperative OutcomesRank
Postoperative Outcomes Least Preferred by Patients
Adapted from Macario A et al. Anesth Analg. 1999;89:652–658. © 1999. With permission from Lippincott Williams & Wilkins.
Data from a survey of adult patients (N=101) conducted at Stanford University Medical Center. Patients were eligible if they were scheduled to undergo surgery at the center. Patients were asked to rank-order 10 possible postoperative outcomes from most to least desirable. F-test <0.01.
Emesis is the postoperative outcome least preferred by patients
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$18.05 $17.86$16.96
$13.82$11.82
$7.99 $7.60
$3.04
$-
$5
$10
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Vomiting Gagging on ETTube
Pain Recall w/outPain
Nausea ResidualWeakness
Shivering Sore Throat
Ranking and Relative Values ($100) of Patient Outcomes*
“… avoiding Post-Operative Nausea and Vomiting seems to be a high priority for most Patients”1
Macario, A, et al Which Clinical Anesthesia Outcomes; Anesth Anal, 1999; 89;652-8
What do Surgical Patients Most Want to Avoid?
*Patients were asked to distribute $100 among 10 outcomes, with proportionally more money being allocated to the more undesirable outcomes (eg, patients assigned $18.05 of $100 to avoid vomiting).
n=62
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Cost Components in PONV Episodes
PACU nurses78%
MD/CRNA5%
Personnel83%
*Per item of basin, gloves, paper, linen, and gown
Antiemetic cost3%
Materials*0.2%
PACU delay4%
Hospital admission
10%
Cost Components for an Episode of Emesis(% total median management cost per patient)
Hill RP et al. Anesthesiology. 2000;92:958-967.
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PONV Incurs Higher Cost$
• In a study conducted in 2000, PONV was associated with increased cost*— A single episode of emesis costs an average of $305— A single episode of nausea costs an average of $82
• PONV is a major factor limiting early discharge of ambulatory surgical patients (1st or 2nd all major studies)
• PONV is a leading cause of unanticipated hospital admissions (24% primary reason)
• Preventing PONV can be cost-effective
Hill RP et al. Anesthesiology. 2000;92:958-967Lau H & Brooks DC. Arch Surg (2001) 136:1150-53.
* PACU personnel costs are biggest component:NOT PHARMACEUTICALS
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The PONV Problem
John B Leslie, MD MBA
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Why do patients develop PONV?
PONVPDNVOIE
MINV
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1180 patients50% pediatric
Apfel BJA 2002;88:659
“Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized
controlled trial of [5x] factorial design.”
750 combinations:Gender, Surgery, Opioids, Maintenance, PONV Prophylaxis
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PONV Risk Prediction Tool?JBL
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PONV Risk Factors
1. Watcha MF, White PF. Anesthesiology. 1992;77:162-184. 2. Kovac AL. Drugs. 2000;59:213-243. 3. Apfel CC, et al. Acta Anaesthesiol Scand. 1998;42:495-501. 4. Apfel CC, et al. Anesthesiology. 1999;91:693-700. 5. Koivuranta M, et al. Anaesthesia. 1997;52:443-449. 6.Apfel CC, Roewer N. Int Anesthesiol Clin. 2003;41:13-32. 7. Apfel CC. Anesthesiology News Special Edition. 2006:71-76.
• Patient related1-7
—Female gender—History of PONV and/or motion sickness—Nonsmokers—Younger age—Anxiety—Underlying disease (e.g., GI obstruction,
neuromuscular disorders, gastric hypomotility)
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PONV Risk Factors (cont)
1. Watcha MF, White PF. Anesthesiology. 1992;77:162-184. 2. Kovac AL. Drugs. 2000;59:213-243. 3. Apfel CC, et al. Br J Anaesth. 2002;88:659-668. 4. Cohen MM, et al. Anesth Analg. 1994;78:7-16. 5. Koivuranta M, et al. Anaesthesia. 1997;52:443-449. 6. Apfel CC, et al. Anaesthesia. 2004;59:1078-1082. 7. Roberts GW, et al. Anesth Analg. 2005;101:1343-1348. 8. Apfel CC, et al. Anesthesiology. 1999;91:693-700.
• Surgery related1-5
—Duration of surgery—Operative procedure (e.g., gynecologic,
laparoscopic, eye, plastic, abdominal)
• Anesthesia related1-3,6-8
—Volatile anesthetics—General anesthesia—Duration of anesthesia—Postoperative opioids—Muscle relaxant antagonists (e.g., neostigmine)
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The PONV Problem
John B Leslie, MD MBA
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PONV Risk Factors (cont)
1. Kovac AL. Drugs. 2000;59:213-243. 2. Apfel CC, et al. Anesthesiology. 1999;91:693-700. 3. Apfel CC. Anesthesiology News Special Edition. 2006:71-76.
• Most predictive1-3
—Female gender—Nonsmokers—History of PONV/motion sickness—Postoperative opioid analgesics
• Multiple (≥3) risk factors2
—60%–80% of patients may experience PONV
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Apfel Koivuranta
Palazzo Sinclair
Comparison of predictive models for PONV
Apfel et al. Br J Anaesth 2002;88:234-40
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1137 ENT patients split into an evaluation set (533) and a validation set (584)
“A risk score to predict the probability of postoperative vomiting in adults.”
• POV Risk (probability) = 11 + e-z
• Where: Z = (no=0, yes=1)+ 1.28*(female gender)- 0.029*(age)- 0.74*(smoking)+ 0.63*(history motion sickness or PONV)+ 0.26*(duration)- 0.92
Apfel et al. Acta Anaesthesiol Scand 1998;42:495-501
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SAMBA Algorithm Factors for PONV
Gan et al. Anesth Analg. 2007;105:1615-28.
Adult Risk Factors Children Risk Factors
Patient Related EnvironmentalSurgery > 30 min
History of PONV or Motion Sickness
Postop Opioids Age > 3 years
Female Gender Emetogenic surgery (type & duration)
Strabismus surgery
Non-Smoker History of POV or relative with PONV
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Simplified Risk Score to Predict PONV in Adults1
1. Gan TJ, et al Guidelines for the Management of PONV; Anesth Anal, Vol 105, December, 2007
Risk Factors Points
Female Gender 1
Non-Smoker 1
History of PONV** 1
Postoperative Opioids 1
Sum = 0, 1, 2, 3, 4
When either 1, 2, 3 or 4 of the independent PONV predictors are present, the corresponding risk for PONV increases
For example (YELLOW BOX), if a patient is a “female” “non-smoker”she has 2 risk factors and there is a 40% chance of her experiencing PONV
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4 RiskFactors** or motion sickness?
Percent Risk for PONV
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Where are we in the development and implementation of “best practices” PONV guidelines?
PONVPDNVOIE
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The PONV Problem
John B Leslie, MD MBA
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PONV Patient-At-Risk “Game Plan”JBL
Strategies to Reduce Baseline PONV Risk
• Avoidance of general anesthesia by the use of regional anesthesia (RCT)
• Use of propofol for induction and maintenance of anesthesia (RCT/SR)
• Avoidance of nitrous oxide (RCT/SR)• Avoidance of volatile anesthetics (RCT)• Minimization of intraoperative and postoperative
opioids (RCT/SR)• Minimization of neostigmine (SR)• Adequate hydration (RCT)
Gan et al. Anesth Analg. 2007;105:1615-28.
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Guidelines for Antiemetic Prophylaxis for PONV
ASA=American Society of Anesthesiologists; ASPAN=American Society of PeriAnesthesia Nurses; SAMBA=Society for Ambulatory Anesthesia.1. ASA Task Force on Postanesthetic Care. Anesthesiology. 2002;96:742-752. 2. ASPAN PONV/PDNV Strategic Work Team. J Perianesth Nurs. 2006;21:230-250. 3. Gan TJ, et al. Anesth Analg. 2007;105:1615-1628.
ASA 20021 ASPAN 20062 SAMBA 20073
• Prophylaxis with:—5-HT3 RA—Droperidol—Dexamethasone—Metoclopramide—5-HT3 RA +
dexamethsone • If required, rescue with 5-HT3 RA
• Prophylaxis with 1 or more: —5-HT3 RA—Droperidol —Dexamethasone —H1 receptor blocker—Transdermal scopolamine patch
• Give adequate IV hydration• Use total IV anesthesia• If patient fails in PACU, then administer another category of agent
• If required, rescue with promethazine, prochlorperazine, or metoclopramide
• Assess patient risk• Reduce baseline risk factors• Prophylaxis with 1-2 interventions for patients at moderate risk:
—5-HT3 RA—Droperidol, haloperidol—Dexamethasone—H1 receptor blocker—Transdermal scopolamine
patch—Promethazine,
prochlorperazine, perphenazine—Ephedrine
• High-risk multimodal approach
• If patient fails, then administer another category of agent
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PONV AntiemeticsReceptor Site Affinity
1. Watcha MF, White PF. Anesthesiology. 1992;77:162-184. 2. Scuderi PE. Int Anesthesiol Clin. 2003;41:41-66. 3. Prommer E. J Pain Palliat Care Pharmacother. 2005;19:31-39.
Drug FDAApproved
Receptor Site Affinity
Serotonin Dopamine Histamine Muscarinic Neurokinin
Prochlorperazine + + + + + + + + +
Haloperidol + + + + +
Droperidol + + + + + +
Metoclopramide + + + + + +
Scopolamine + + + + + +
Dimenhydrinate + + + + + + +
Hydroxyzine + + + + + + +
Promethazine + + + + + + + +
Aprepitant + + + +
Dolasetrron + + + +
Granisetron + + + +
Ondansetron + + + +
Palonosetron + + + +
Dexamethasone Antagonism of prostaglandins and release of endorphins
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Anesthesiologists & Nurse Anesthetists
Gan TJ, et al Guidelines for the Management of PONV; Anesth Analgesia, Vol 105, December, 2007
The Consensus Guidelines for the management of PONV was written by a multi-disciplinary panel that included such clinicians as …
Surgeons
Peri-Anesthesia Nurse
Pharmacist
PONV Treatment TeamJBL
SAMBA Treatment Algorithm Options for PONV
Gan et al. Anesth Analg. 2007;105:1615-28.
The PONV Problem
John B Leslie, MD MBA
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SAMBA Treatment Algorithm Options for PONV
Gan et al. Anesth Analg. 2007;105:1615-28.
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SAMBA Treatment Algorithm Options for PONV
Gan et al. Anesth Analg. 2007;105:1615-28.
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Selecting “Best Shot” PONV/PDNV Drugs?JBL
Increasing the Number of Antiemetics Reduces the Incidence of PONV (n=5161 patients at high risk for PONV)
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No Antiemetic 1 Antiemetic 2 Antiemetics 3 Antiemetics
% In
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0 Antiemetics 1 Antiemetic
IV Ondansetron IV Dexamethasone
IV Droperidol
2 Antiemetics
IV Ond + IV Dex IV Ond + IV DroIV Dro + IV Dex
3 Antiemetics
52% chance of PONV
37% chance of PONV
28% chance of PONV22% chance of PONV
Adapted from Apfel et al. N Engl J Med. 2004;350:2241-2251.
95% Confidence Interval
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Adapted from Apfel et al. N Engl J Med. 2004;350:2241-2251.
Estimated Incidence of PONV as a function of Baseline RiskAssumption: Each Intervention Reduces risk by 26%1
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TwoInterventions
ThreeInterventions
FourInterventions
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n=5161 patients at risk for PONV
26% reduction in relative risk of PONV for each additional antiemetic used
The baseline risk levels 0f 10%, 20%, 40%, 60% and 80% reflect the presence of 0,1,2,3 and 4 risk factors respectively, according to a simplified score
80% baseline risk 4 Risk Factors
60% baseline risk 3 Risk Factors
40% baseline risk 2 Risk Factors
20% baseline risk 1 Risk Factor
10% baseline risk 0 Risk Factors
JBLDespite multiple combinations with current drugs, we fail…yes, we fail!
Number of interventionsBaseline risk
(no intervention)1 2 3 4
10% 7% 5% 4% 3%
20% 15% 11% 8% 6%
40% 29% 22% 16% 12%
60% 44% 33% 24% 18%
80% 59% 44% 32% 24%
Estimated PONV incidence as a function of baseline risk, assuming each intervention reduces relative risk by 26%
Apfel CC, Korttila K, Abdalla M, et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med 2004;350:2441-51.
The PONV Problem
John B Leslie, MD MBA
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Selecting the Ideal Antiemetic? Pathway?The Numbers are In. We Are Failing ;-(
JBLCurrent & Future Antiemetic Therapy for PONV Prophylaxis in Adults
• Serotonin (5-HT3) antagonists— Ondansetron (Zofran®)— Dolasetron (Anzemet®)— Granisetron (Kytril®)— Tropisetron (Navoban®)*— Palonosetron (Aloxi®)
• Dexamethasone (Decadron®)*• Droperidol (Inapsine®)†
— Haloperidol (Haldol®)*• Scopolamine (Transderm Scop®)• Promethazine (Phenergan®)• Prochlorperazine (Compazine®)• Ephedrine*
• Diphenhydramine (Benadryl®)• Nonpharmacologic
techniques*— Acupuncture* (Acupressure)*— Hypnosis*— Aromatherapy*— Music therapy*
• Dimenhydrinate (Dramamine®)• Neurokinin-1 Antagonists
— Aprepitant (Emend®)— Casopitant (Rezonic)* 5-20-09
• Cannabinoid— Nabilone (Cesamet®)*— Dronabinol (Marinol®)*
*Currently not FDA-approved for PONV in the United States; †Note package insert black box warning.Modified from Gan et al. Anesth Analg. 2003;97:62-71.
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PONV Summary and Conclusions
• PONV: Ranked as most undesirable consequence of surgery 1— 30% overall incidence 2— PONV incidence increases with each additional risk factor, thus
underscoring need for assessment and preventative intervention 3
• Risk assessment helps identify patients who would benefit from prophylactic antiemetics
• Effective PONV prevention strategy incorporates risk assessment that reflects its multifactorial etiology 2
• Global risk assessment includes evaluation of: 2
— Patient-related characteristics— Surgery-related characteristics— Anesthesia-related characteristics
1. Macario A., et al. Anesth Analg 1999;89:652-658. 2. Kovac. Drugs. 2000;59:213-243. 3. Apfel CC et al. Anesthesiology 1999;91:693-700
JBLPONV Summary and Conclusions(cont)
• Understanding of emetic pathways continues to evolve— Peripheral versus central emetogenic triggers 1,2
— Peripheral versus central neurotransmitter/receptor pathways 3.4
• Involvement of different emetic neurotransmitter pathways may impact treatment strategies— Source of emetic stimuli impacts effectiveness of
pharmacologic antiemetic intervention 5
— Multiple receptor approach probably logical and effective• Ideal combination unproven: Consider 5-HT3 + steroid +
droperidol/haloperidol + SCOP + “special needs” + techniques— New pharmacology 5HT3 antagonist palonosetron— First substance P/NK1 antagonist now available for prevention
of troublesome PONV and PDNV: Aprepitant 40 mg
1. Kovac. Drugs. 2000;59:213-243. 2. Nelson TP. J PeriAnesthesia Nursing 2002;17:178-189. 3. Saito R., et al. J Pharmacol Sci 2003;91:87-94. 4. Hornby PJ. Amer J Med 2001;111:106S-112S. 5. Diemunsch P., Grelot L. Drugs 2000;60:533-546
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SCOAP PONV Challenge
Risk stratification can and should be done.Prevention measures should be implemented.Outcome benefits should be producible and
measurable.Benefits should include patient satisfaction and
reduced costs.The PONV initiative should be widely applicable.
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Questions?