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Prevention and Treatment of Postoperative Nausea and Vomiting

Critical Evaluation of Data. Quality of individual clinical trialsEvaluation of data in aggregateEstimation of treatment consequences. Evidence Based Medicine Rating Scale. Level of evidence based on study designI. Large randomized, controlled trial (n>100 per group)II. Systematic reviewIII

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Prevention and Treatment of Postoperative Nausea and Vomiting

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    1. Prevention and Treatment of Postoperative Nausea and Vomiting Phillip E. Scuderi, M.D. Department of Anesthesiology Wake Forest University School of Medicine Winston-Salem, NC 27157-1009

    2. Critical Evaluation of Data Quality of individual clinical trials Evaluation of data in aggregate Estimation of treatment consequences

    3. Evidence Based Medicine Rating Scale Level of evidence based on study design I. Large randomized, controlled trial (n>100 per group) II. Systematic review III. Small randomized, controlled trial (n<100 per group) IV. Nonrandomized controlled trial or case report V. Expert opinion Strength of Recommendation based on expert opinion A. Good evidence to support the recommendation B. Fair evidence to support the recommendation C. Insufficient evidence to recommend for or against

    4. Measures of Treatment Consequences Relative Risk Reduction The reduction of adverse events achieved by a treatment, expressed as a proportion of the control rate Odds Ratio The traditional expression of the relative likelihood of an outcome expressed as P/(1 - P) where P = probability Absolute Risk Reduction The difference in event rates between the control and treatment groups Numbers Needed to be Treated (NNT) The number of patients who must be treated in order to prevent one adverse event. It is mathematically equivalent to the reciprocal of the absolute risk reduction.

    5. Measures of Treatment Consequences

    6. Chemoreceptor Receptor Zone

    8. Currently Available Medications 5HT3 (serotonin) antagonists - ondansetron Butyrophenones - droperidol Benzamides - metoclopramide Antihistamines - promethazine, dimenhydrinate Steroids - dexamethasone Phenothiazines- promethazine, prochlorperazine Anticholinergics – scopolamine

    9. Evidence Rating for Antiemetics

    10. Prevention of PONV: Ondansetron Versus Placebo Randomized, double blind prospective placebo controlled dose ranging. Females 18 - 70 yo outpatients undergoing gyn surgery. Stratified by prior history of PONV. Total of 580 patients enrolled, 544 patients evaluated. Standard anesthetic including barbiturate, opioid, isoflurane or enflurane, NMB agent with reversal and nitrous oxide. Study medication administered immediately before induction.Randomized, double blind prospective placebo controlled dose ranging. Females 18 - 70 yo outpatients undergoing gyn surgery. Stratified by prior history of PONV. Total of 580 patients enrolled, 544 patients evaluated. Standard anesthetic including barbiturate, opioid, isoflurane or enflurane, NMB agent with reversal and nitrous oxide. Study medication administered immediately before induction.

    11. Ondansetron Dose Response: Prevention

    12. Evidence Rating for Antiemetics

    13. Treatment of PONV: Ondansetron Versus Placebo Randomized, prospective, double blind, placebo controlled, dose ranging. Two parallel studies performed. Multicenter with 20 total sites. Over 2500 total patients enrolled, 1000 patients (500 in each study) received study medication. 90 % female. Standard anesthetic included barbiturate, opioid, NMB agent and reversal, nitrous and either isoflurane or enflurane. Complete response defined as no vomiting, no rescue medication.Randomized, prospective, double blind, placebo controlled, dose ranging. Two parallel studies performed. Multicenter with 20 total sites. Over 2500 total patients enrolled, 1000 patients (500 in each study) received study medication. 90 % female. Standard anesthetic included barbiturate, opioid, NMB agent and reversal, nitrous and either isoflurane or enflurane. Complete response defined as no vomiting, no rescue medication.

    14. Ondansetron Dose Response: Treatment

    15. Evidence Rating for Antiemetics

    16. Prevention of PONV: Dolasetron Versus Placebo Randomized, double blind, placebo controlled, dose ranging. multicenter (25) trial. 635 females undergoing outpatient laparoscopy. Standard anesthetic including barbiturate, NMB, reversal, opioid, and isoflurane. Study medication was administered 15 before discontinuation of nitrous oxide. Followed for 24 hours. Complete response defined as no vomiting and no rescue antiemetic.Randomized, double blind, placebo controlled, dose ranging. multicenter (25) trial. 635 females undergoing outpatient laparoscopy. Standard anesthetic including barbiturate, NMB, reversal, opioid, and isoflurane. Study medication was administered 15 before discontinuation of nitrous oxide. Followed for 24 hours. Complete response defined as no vomiting and no rescue antiemetic.

    17. Treatment of PONV: Dolasetron Versus Placebo Randomized, double blind, placebo controlled, dose ranging study. Multicenter trial at 30 sites. 1557 adults undergoing outpatient surgery were enrolled. Standard anesthetic included barbiturate, opioid, nitrous oxide, isoflurane, NMB if required, reversal of NMB if indicated. The subset of those who experienced PONV (620, 40%) were stratified by gender (106 males, 514 females). Entered into treatment if patient had one or more emetic episodes within two hr postop and or nausea lasting longer than 5 min reported as moderate to severe.Randomized, double blind, placebo controlled, dose ranging study. Multicenter trial at 30 sites. 1557 adults undergoing outpatient surgery were enrolled. Standard anesthetic included barbiturate, opioid, nitrous oxide, isoflurane, NMB if required, reversal of NMB if indicated. The subset of those who experienced PONV (620, 40%) were stratified by gender (106 males, 514 females). Entered into treatment if patient had one or more emetic episodes within two hr postop and or nausea lasting longer than 5 min reported as moderate to severe.

    18. Evidence Rating for Antiemetics

    19. Prevention of PONV: Granisetron Versus Placebo Multicenter at 35 centers and 8 countries in Europe, Scandinavia, and South Africa. 527 patients were randomized to receive either placebo or one of 3 doses of granisetron. Males and females included.Multicenter at 35 centers and 8 countries in Europe, Scandinavia, and South Africa. 527 patients were randomized to receive either placebo or one of 3 doses of granisetron. Males and females included.

    20. Prevention of PONV: Granisetron Versus Placebo Multicenter at 35 centers and 8 countries in Europe, Scandinavia, and South Africa. 527 patients were randomized to receive either placebo or one of 3 doses of granisetron. Males and females included.Multicenter at 35 centers and 8 countries in Europe, Scandinavia, and South Africa. 527 patients were randomized to receive either placebo or one of 3 doses of granisetron. Males and females included.

    21. Prevention of PONV: Granisetron Versus Placebo Multicenter at 35 centers and 8 countries in Europe, Scandinavia, and South Africa. 527 patients were randomized to receive either placebo or one of 3 doses of granisetron. Males and females included.Multicenter at 35 centers and 8 countries in Europe, Scandinavia, and South Africa. 527 patients were randomized to receive either placebo or one of 3 doses of granisetron. Males and females included.

    22. Treatment of PONV: Granisetron Versus Placebo Multicenter at 34 centers and 9 countries in Europe, Scandinavia, and South Africa. 519 patients who developed symptoms of PONV within 4 hr of surgery under general anesthesia. Randomized, double blind, placebo controlled, dose ranging. Males and females included.Multicenter at 34 centers and 9 countries in Europe, Scandinavia, and South Africa. 519 patients who developed symptoms of PONV within 4 hr of surgery under general anesthesia. Randomized, double blind, placebo controlled, dose ranging. Males and females included.

    23. Treatment of PONV: Granisetron Versus Placebo Multicenter at 34 centers and 9 countries in Europe, Scandinavia, and South Africa. 519 patients who developed symptoms of PONV within 4 hr of surgery under general anesthesia. Randomized, double blind, placebo controlled, dose ranging. Males and females included. Multicenter at 34 centers and 9 countries in Europe, Scandinavia, and South Africa. 519 patients who developed symptoms of PONV within 4 hr of surgery under general anesthesia. Randomized, double blind, placebo controlled, dose ranging. Males and females included.

    24. Evidence Rating for Antiemetics

    25. Prevention of PONV: Ondansetron Versus Droperidol Combination of two randomized, double blind placebo controlled trials. 2061 adult outpatients at increased risk for PONV enrolled. Study medication administered 20 min before induction of anesthesia. Standard anesthetic regimen included barbiturate induction, nitrous oxide, and either isoflurane or enflurane. Complete response defined as no emesis, no rescue. No difference in patient satisfaction among active groups. All were better than placebo.Combination of two randomized, double blind placebo controlled trials. 2061 adult outpatients at increased risk for PONV enrolled. Study medication administered 20 min before induction of anesthesia. Standard anesthetic regimen included barbiturate induction, nitrous oxide, and either isoflurane or enflurane. Complete response defined as no emesis, no rescue. No difference in patient satisfaction among active groups. All were better than placebo.

    26. Prevention of PONV: Ondansetron Versus Droperidol Combination of two randomized, double blind placebo controlled trials. 2061 adult outpatients at increased risk for PONV enrolled. Study medication administered 20 min before induction of anesthesia. Standard anesthetic regimen included barbiturate induction, nitrous oxide, and either isoflurane or enflurane. Complete response defined as no emesis, no rescue. No difference in patient satisfaction among active groups. All were better than placebo.Combination of two randomized, double blind placebo controlled trials. 2061 adult outpatients at increased risk for PONV enrolled. Study medication administered 20 min before induction of anesthesia. Standard anesthetic regimen included barbiturate induction, nitrous oxide, and either isoflurane or enflurane. Complete response defined as no emesis, no rescue. No difference in patient satisfaction among active groups. All were better than placebo.

    27. Droperidol FDA Box Warning

    28. Droperidol Adverse Events Reports 273 “reports” from 1997-2001 127 serious adverse events 89 total deaths Droperidol 1.25 mg or less 10 cases 5 VT/VF 2 deaths

    29. Droperidol and QTc Prolongation Effect of Low-dose Droperidol on the QT Interval during and after General Anesthesia White et al. Anesthesiology 2005; 102:1101-1105 Prolongation of QTc Interval after Postoperative Nausea and Vomiting Treatment by Droperidol or Ondansetron Charbit et al. Anesthesiology 2005; 102:1094-1100 You (Still) Can’t Disprove the Existence of Dragons Scuderi. Anesthesiology 2005; 102:1081-1082

    30. Droperidol: The FDA Box Warning Droperidol has been used for over 40 years Why a problem now? No evidence of adverse events in published trials No published case reports An association does not prove cause and effect If prolonged QTc is an issue then 5HT3 antagonists should also carry the same warning At least 3 cases of VT associated with 5HT3 administration No “denominator” provided (or available)

    31. BOGUS! Droperidol FDA Box Warning

    32. Evidence Rating for Antiemetics

    33. Prevention of PONV: Dexamethasone “In conclusion, in the surgical setting, a single prophylactic dose of dexamethasone is antiemetic compared with placebo without evidence of clinically relevant toxicity in otherwise healthy patients. Late efficacy (i.e., Up to 24 hours) seems to be most pronounced.”

    34. Evidence Rating for Antiemetics

    35. Prevention of PONV: Dimenhydrinate

    36. Evidence Rating for Antiemetics

    37. Evidence Rating for Antiemetics

    38. Prevention of PONV: Metoclopramide “In summary, metoclopramide, although used as an antiemetic for almost 40 years in the prevention of PONV, has no clinically relevant antiemetic effect . . . it is very likely that the doses used in daily clinical practice are too low.”

    39. Evidence Rating for Antiemetics

    40. Prevention of PONV: Scopolamine

    41. Prevention of PONV: Scopolamine

    42. Evidence Rating for Antiemetics

    43. Ondansetron and Dolasetron Perception versus Reality Browning BA, Fort CA, Kemp KD, Shimata MF, Strube MD: Ondansetron versus dolasetron: a comparison study in the prevention of postoperative nausea and vomiting in patients undergoing gynecological procedures. AANA.J. 2004; 72: 129-32 Karamanlioglu B, Turan A, Memis D, Sut N: Comparison of oral dolasetron and ondansetron in the prophylaxis of postoperative nausea and vomiting in children. Eur.J.Anaesthesiol. 2003; 20: 831-5 Olutoye O, Jantzen EC, Alexis R, Rajchert D, Schreiner MS, Watcha MF: A comparison of the costs and efficacy of ondansetron and dolasetron in the prophylaxis of postoperative vomiting in pediatric patients undergoing ambulatory surgery. Anesth.Analg. 2003; 97: 390-6 Walker JB: Efficacy of single-dose intravenous dolasetron versus ondansetron in the prevention of postoperative nausea and vomiting. Clin.Ther. 2001; 23: 932-8

    44. Ondansetron and Dolasetron Perception versus Reality Paech MJ, Rucklidge MW, Banks SL, Gurrin LC, Orlikowski CE, Pavy TJ: The efficacy and cost-effectiveness of prophylactic 5-hydroxytryptamine3 receptor antagonists: tropisetron, ondansetron and dolasetron. Anaesth.Intensive Care 2003; 31: 11-7 Sukhani R, Pappas AL, Lurie J, Hotaling AJ, Park A, Fluder E: Ondansetron and dolasetron provide equivalent postoperative vomiting control after ambulatory tonsillectomy in dexamethasone-pretreated children. Anesth.Analg. 2002; 95: 1230-5 Zarate E, Watcha MF, White PF, Klein KW, Sa RM, Stewart DG: A comparison of the costs and efficacy of ondansetron versus dolasetron for antiemetic prophylaxis. Anesth.Analg. 2000; 90: 1352-8

    45. Prevention of PONV: Combination Therapy McKenzie R, et al. Comparison of ondansetron with ondansetron plus dexamethasone in the prevention of postoperative nausea and vomiting. Anesth Analg 1994;79:961-964 Lopez-Olaondo L, et al. Combination of ondansetron and dexamethasone in the prophylaxis of postoperative nausea and vomiting. BJA 1996;76:835-840 Eberhart LH. Morin AM. Georgieff M. Dexamethasone for prophylaxis of postoperative nausea and vomiting. A meta-analysis of randomized controlled studies. Anaesthetist. 2000 ;49:713-20 (meta analysis)

    46. Prevention of PONV: Combination Therapy Pueyo FJ, et al. Combination of ondansetron and droperidol in the prophylaxis of postoperative nausea and vomiting. Anesth Analg 1996;83:117-122 McKenzie R, et al. Droperidol/ondansetron combination controls nausea and vomiting after tubal banding. Anesth Analg 1996;83:1218-1222 Klockgether-Radke A, et al. Ondansetron, droperidol and their combination for the prevention of post-operative vomiting in children. Eur J Anesthesiology. 1997;14:362-367 Eberhart LH. Morin AM. Bothner U. Georgieff M. Droperidol and 5HT3-receptor antagonists, alone or in combination, for prophylaxis of postoperative nausea and vomiting. A meta-analysis of randomized controlled trials. Acta Anaesthesiologica scandinavica. 2000;44:1252-7

    47. Prevention of PONV: Combination Therapy Meta analysis, 27 studies identified, 2 excluded. 1311 patients analyzed. Combination of droperidol and ondansetron (298) or granisetron (200). Combination of dexamethasone and ondansetron (280), granisetron (467) or tropisetron (66). 20 trials in adults, 5 in children.Meta analysis, 27 studies identified, 2 excluded. 1311 patients analyzed. Combination of droperidol and ondansetron (298) or granisetron (200). Combination of dexamethasone and ondansetron (280), granisetron (467) or tropisetron (66). 20 trials in adults, 5 in children.

    48. Prevention of PONV: Timing of Administration Sun et al. The effect of timing on ondansetron administration in outpatients undergoing otolaryngologic surgery. Anesth Analg 1997;84:331-336 Chen et al. The effect of timing of dolasetron administration on its efficacy as a prophylactic antiemetic in the ambulatory setting. Anesth Analg 2001;93:906-911 Wang et al. The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg 2000;91;136-139

    49. Breakthrough PONV: Repeat Dosing With Ondansetron Randomized, double blind placebo controlled multicenter study to evaluate the effect of an additional 4 mg of ondansetron for treatment of breakthrough PONV occurring in PACU in outpatients who received ondansetron 4 mg as prophylaxis. 2199 male and female patients enrolled. 428 patients experienced PONV or requested antiemetics were randomized to receive an addition dose of 4 mg of ondansetron or placebo. Complete response defined as no emesis or no rescue medication.Randomized, double blind placebo controlled multicenter study to evaluate the effect of an additional 4 mg of ondansetron for treatment of breakthrough PONV occurring in PACU in outpatients who received ondansetron 4 mg as prophylaxis. 2199 male and female patients enrolled. 428 patients experienced PONV or requested antiemetics were randomized to receive an addition dose of 4 mg of ondansetron or placebo. Complete response defined as no emesis or no rescue medication.

    50. Propofol and PONV

    51. Propofol and PONV CACI devise targeted plasma concentrations of 100, 200, 400, and 800 ng/ml. Median plasma concentration associated with antiemetic response - 343 ng/ml. 17 mcg/kg/min propofol yields 400 - 540 ng/ml plasma concentration CACI devise targeted plasma concentrations of 100, 200, 400, and 800 ng/ml. Median plasma concentration associated with antiemetic response - 343 ng/ml. 17 mcg/kg/min propofol yields 400 - 540 ng/ml plasma concentration

    52. Propofol “PCA” Three medications per delivery: propofol 20mg, propofol 40 mg, or placebo. Lockout interval 5 min, no maximum dose limit. Nausea scores were 34% and 40% less than placebo. Placebo group had an 8 and 5 fold increase in risk of emesis and a 5 fold increase in incidence of rescue. No differences in sedation. Patients in treatment groups were more satisfied than those in placebo group Three medications per delivery: propofol 20mg, propofol 40 mg, or placebo. Lockout interval 5 min, no maximum dose limit. Nausea scores were 34% and 40% less than placebo. Placebo group had an 8 and 5 fold increase in risk of emesis and a 5 fold increase in incidence of rescue. No differences in sedation. Patients in treatment groups were more satisfied than those in placebo group

    53. Intravenous Fluid Therapy

    54. Intravenous Fluid Therapy 141 ASA I females undergoing elective gyn laparoscopy randomized to receive in double blind fashion either 10 ml/kg or 30 ml/kg compound sodium lactate. Standard anesthetic with fentanyl, propofol, atracurium, and sevoflurane, nitrous oxide, and oxygen for maintenance. All had NMB reversal with neostigmine and glycopyrrolate. No prophylactic antiemetics. PONV treated with ondansetron 4 mg IV and prochlorperazine 12.5 mg IM.141 ASA I females undergoing elective gyn laparoscopy randomized to receive in double blind fashion either 10 ml/kg or 30 ml/kg compound sodium lactate. Standard anesthetic with fentanyl, propofol, atracurium, and sevoflurane, nitrous oxide, and oxygen for maintenance. All had NMB reversal with neostigmine and glycopyrrolate. No prophylactic antiemetics. PONV treated with ondansetron 4 mg IV and prochlorperazine 12.5 mg IM.

    55. Intravenous Fluid Therapy Preoperative Intravenous Fluid Therapy Decreases Postoperative Nausea and Pain in High Risk Patients Maharaj et al. Anesth Analg 2005; 100:675-682

    56. NK-1 Antagonists: Prevention Randomized, double-blind, placebo controlled, multicenter design. 243 females undergoing abdominal hysterectomy. Dose ranging portion – 100 mg or 200 mg p.o. versus placebo before surgery. Interaction portion – 200 mg of CP122,721 or placebo p.o. before surgery followed by ondansetron 4 mg or placebo IV at end of surgery. Standard anesthetic with thiopental induction, NMB, potent inhalation agent with nitrous oxide, and NMB reversal at end of surgeryRandomized, double-blind, placebo controlled, multicenter design. 243 females undergoing abdominal hysterectomy. Dose ranging portion – 100 mg or 200 mg p.o. versus placebo before surgery. Interaction portion – 200 mg of CP122,721 or placebo p.o. before surgery followed by ondansetron 4 mg or placebo IV at end of surgery. Standard anesthetic with thiopental induction, NMB, potent inhalation agent with nitrous oxide, and NMB reversal at end of surgery

    57. NK-1 Antagonists: Treatment

    58. Prevention of PONV: Clonidine

    59. Prevention of PONV: Clonidine

    60. Prevention of PONV: Haloperidol Is Low-dose Haloperidol a Useful Antiemetic? Buttner et al. Anesthesiology 2004; 101:1454-1463

    61. P-6 Acupuncture Point Stimulation Zarate E, Mingus M, White PF, Chiu JW, Scuderi PE, et al. The use of transcutaneous acupoint electrical stimulation for preventing nausea and vomiting after laparoscopic surgery. Anesth Analg 2001;92:629-35. Multicenter (4), randomized, double blind, placebo and sham controlled. 250 adult patients undergoing laparoscopic cholecystectomy. Transcutaneous acupoint electrical stimulation (TAES) applied at Nei-Guan P6 acupuncture point. Sham group had inactive device place at the P6 point with no electrical stimulation. Placebo group had inactive device placed on dorsal surface of wrist. Statistically significant improvement in nausea and severity of nausea of active device compared to placebo and sham. No decrease in the incidence of vomitingMulticenter (4), randomized, double blind, placebo and sham controlled. 250 adult patients undergoing laparoscopic cholecystectomy. Transcutaneous acupoint electrical stimulation (TAES) applied at Nei-Guan P6 acupuncture point. Sham group had inactive device place at the P6 point with no electrical stimulation. Placebo group had inactive device placed on dorsal surface of wrist. Statistically significant improvement in nausea and severity of nausea of active device compared to placebo and sham. No decrease in the incidence of vomiting

    62. P-6 Stimulation: Control of Nausea Multicenter (4), randomized, double blind, placebo and sham controlled. 250 adult patients undergoing laparoscopic cholecystectomy. Transcutaneous acupoint electrical stimulation (TAES) applied at Nei-Guan P6 acupuncture point. Sham group had inactive device place at the P6 point with no electrical stimulation. Placebo group had inactive device placed on dorsal surface of wrist. Statistically significant improvement in nausea and severity of nausea of active device compared to placebo and sham. No decrease in the incidence of vomiting Multicenter (4), randomized, double blind, placebo and sham controlled. 250 adult patients undergoing laparoscopic cholecystectomy. Transcutaneous acupoint electrical stimulation (TAES) applied at Nei-Guan P6 acupuncture point. Sham group had inactive device place at the P6 point with no electrical stimulation. Placebo group had inactive device placed on dorsal surface of wrist. Statistically significant improvement in nausea and severity of nausea of active device compared to placebo and sham. No decrease in the incidence of vomiting

    63. P-6 Acupuncture Point Stimulation Randomized, sham controlled, prospective trial. 77 female patients undergoing major breast surgery. P6 accupoint stimulation with HANS dual channel stimulator applied 30 – 60 min before surgery and discontinued at the end of surgery. Standard anesthetic propofol induction, succinylcholine or rocuronium, nitrous oxide 50% in oxygen and fentanyl. Ondansetron or placebo administered at time of induction.Randomized, sham controlled, prospective trial. 77 female patients undergoing major breast surgery. P6 accupoint stimulation with HANS dual channel stimulator applied 30 – 60 min before surgery and discontinued at the end of surgery. Standard anesthetic propofol induction, succinylcholine or rocuronium, nitrous oxide 50% in oxygen and fentanyl. Ondansetron or placebo administered at time of induction.

    64. Multimodal Management of PONV: Hypothesis

    65. Multimodal Management of PONV: Algorithm for Management

    66. Multimodal Management of PONV: Algorithm for Management

    67. Multimodal Management: Results

    68. Multimodal Management of PONV: Simplified Algorithm I. INDUCTION A. PreO2 B. Propofol 2 - 4 mg/kg C. Opioid prn D. NMB prn C. Droperidol 10 mcg/kg D. Decadron 4 - 8 mg II. MAINTENANCE A. Propofol 50 mcg/kg/min B. Potent inhalation agent C. Nitrous oxide prn E. NMB reversal prn III. EMERGENCE A. Ondansetron 1 mg IV B. Suction oropharynx C. Extubate when awake

    69. Multimodal Management of PONV: Simplified Algorithm

    70. PONV Risk Reduction

    71. General Recommendations Use generic drugs for “routine” prophylaxis Treat breakthrough symptoms with 5HT3 antagonists Don’t repeat dose with 5HT3 antagonists for failure Treat/prevent with different classes of antiemetics For “high risk” patients use combination prophylaxis and consider “alternative” therapy Consider propofol infusion as part of anesthetic Hydrate aggressively The best chance for “complete response” is a multimodal approach

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