Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: a non-inferiority randomized controlled trial

Braz J Anesthesiol. 2024 Jan-Feb;74(1):744216. doi: 10.1016/j.bjane.2021.06.020. Epub 2021 Jul 16.

Abstract

Background: We tested the hypothesis that, within the margin of 15% of risk difference, palonosetron is not inferior to ondansetron in reducing the incidence of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy.

Methods: We conducted a double-blind, non-inferiority, randomized, controlled trial of 212 patients aged 18 to 65 years undergoing laparoscopic cholecystectomy under general anesthesia in two secondary care hospitals. Patients were randomly assigned to receive either palonosetron (0.075.ßmg) or ondansetron (8.ßmg) intravenously at induction of anesthesia. Ondansetron (8.ßmg) was also administered 8 and 16.ßhours postoperatively. All anesthetic and surgical procedures were standardized. Patients were evaluated for 24.ßhours postoperatively for the occurrence of PONV.

Results: A high incidence of PONV was observed at 2...6.ßhours postoperatively, with a rate of 36.8% (95% confidence interval [CI] 28.2...46.3) in the palonosetron group, as compared to 43.4% (95% CI 34.4...52.9) in the ondansetron group. The risk difference (95% CI) between palonosetron and ondansetron for PONV was 0 (-10.9 to 10.9) at 0...2.ßhours, -6.6 (-19.4 to 6.5) at 2...6.ßhours, -0.9 (-11.0 to 9.2) at 6...12.ßhours, and -2.8 (-9.6 to 3.6) at 12...24.ßhours. There was no statistically significant difference between the palonosetron and ondansetron groups in the use of rescue medication (dimenhydrinate). There were no adverse events associated with the medications under study.

Conclusion: Palonosetron is not inferior to ondansetron in patients at risk of PONV undergoing laparoscopic cholecystectomy, providing a good option for PONV prophylaxis, as it can be administered in a single dose.

Keywords: Antiemetics; Postoperative nausea and vomiting; Pre-exposure prophylaxis; Risk factors; Therapeutics.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anesthesia, General / adverse effects
  • Antiemetics* / therapeutic use
  • Cholecystectomy, Laparoscopic* / adverse effects
  • Double-Blind Method
  • Humans
  • Ondansetron / therapeutic use
  • Palonosetron
  • Postoperative Nausea and Vomiting / epidemiology
  • Postoperative Nausea and Vomiting / prevention & control
  • Treatment Outcome

Substances

  • Ondansetron
  • Palonosetron
  • Antiemetics