Brazilian Journal of Anesthesiology
https://bjan-sba.org/article/doi/10.1016/j.bjane.2021.06.020
Brazilian Journal of Anesthesiology
Clinical Research

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

Francisco José Chiaradia Davolos; Norma S. Modolo; Leandro G. Braz; Paulo do Nascimento Junior

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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 mg) or ondansetron (8 mg) intravenously at induction of anesthesia. Ondansetron (8 mg) was also administered 8 and 16 hours postoperatively. All anesthetic and surgical procedures were standardized. Patients were evaluated for 24 hours postoperatively for the occurrence of PONV.

Results
A high incidence of PONV was observed at 2–6 hours 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 hours, -6.6 (-19.4 to 6.5) at 2–6 hours, -0.9 (-11.0 to 9.2) at 6–12 hours, and -2.8 (-9.6 to 3.6) at 12–24 hours. 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

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

References

1 LH Eberhart, AM Morin, H Wulf, et al. Patient preferences for immediate postoperative recovery Br J Anaesth, 89 (2002), pp. 760-761

2 GN Kenny Risk factors for postoperative nausea and vomiting Anaesthesia, 49 Suppl (1994), pp. 6-10

3 C.C. Apfel, E. Laara, M. Koivuranta, et al. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers Anesthesiology, 91 (1999), pp. 693-700

4 E.H. Wong, R. Clark, E. Leung, et al. The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro Br J Pharmacol, 114 (1995), pp. 851-859

5 JB Carlisle, CA Stevenson Drugs for preventing postoperative nausea and vomiting Cochrane Database Syst Rev (2006), Article CD004125

6 J. Bhalla, N. Baduni, P. Bansal Comparison of palanosetron with ondansetron for postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anesthesia J Minim Access Surg, 11 (2015), pp. 193-197

7 S.H. Kim, J.Y. Hong, W.O. Kim, et al. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study Korean J Anesthesiol, 64 (2013), pp. 517-523

8 SK Park, EJ Cho A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery J Int Med Res, 39 (2011), pp. 399-407

9 S. Swaika, A. Pal, S. Chatterjee, et al. Ondansetron, ramosetron, or palonosetron: Which is a better choice of antiemetic to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy? Anesth Essays Res, 5 (2011), pp. 182-186

10 M.R. Tramer, D.J. Reynolds, R.A. Moore, et al. Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials Anesthesiology, 87 (1997), pp. 1277-1289

11 A. Bestas, S.A. Onal, M.K. Bayar, et al. Effects of ondansetron and granisetron on postoperative nausea and vomiting in adult patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled clinical trial Curr Ther Res Clin Exp, 68 (2007), pp. 303-312

12 Y. Erhan, E. Erhan, H. Aydede, et al. Ondansetron, granisetron, and dexamethasone compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized placebo-controlled study Surg Endosc, 22 (2008), pp. 1487-1492

13 SA Helmy Prophylactic anti-emetic efficacy of ondansetron in laparoscopic cholecystectomy under total intravenous anaesthesia. A randomised, double-blind comparison with droperidol, metoclopramide and placebo Anaesthesia, 54 (1999), pp. 266-271

14 AM Kaki, EE Abd El-Hakeem Prophylaxis of postoperative nausea and vomiting with ondansetron, metoclopramide, or placebo in total intravenous anesthesia patients undergoing laparoscopic cholecystectomy Saudi Med J, 29 (2008), pp. 1408-1413

15 M.A. Liberman, S. Howe, M. Lane Ondansetron versus placebo for prophylaxis of nausea and vomiting in patients undergoing ambulatory laparoscopic cholecystectomy Am J Surg, 179 (2000), pp. 60-62

16 M Malik, AJ Camm Evaluation of drug-induced QT interval prolongation: implications for drug approval and labelling Drug Saf, 24 (2001), pp. 323-351

17 H.J. Kim, H.C. Lee, Y.S. Jung, et al. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia Br J Anaesth, 112 (2014), pp. 460-468

18 Q. Liu, C. Zhou, Z. Bao, et al. Effects of palonosetron and ondansetron on preventing nausea and vomiting after laparoscopic surgery J Int Med Res, 46 (2018), pp. 411-420

19 G. Piaggio, D.R. Elbourne, S.J. Pocock, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement JAMA, 308 (2012), pp. 2594-2604

20 K. Leksowski, P. Peryga, R. Szyca Ondansetron, metoclopramid, dexamethason, and their combinations compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a prospective randomized study Surg Endosc, 20 (2006), pp. 878-882

21 T.J. Gan, P. Diemunsch, A.S. Habib, et al. Consensus guidelines for the management of postoperative nausea and vomiting Anesth Analg, 118 (2014), pp. 85-113

22 Y. Fujii, M. Itakura Reduction of postoperative nausea, vomiting, and analgesic requirement with dexamethasone for patients undergoing laparoscopic cholecystectomy Surg Endosc, 24 (2010), pp. 692-696

23 J.T. Mondick, B.M. Johnson, L.J. Haberer, et al. Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1-48 months Eur J Clin Pharmacol, 66 (2010), pp. 77-86

24 S. Paventi, A. Santevecchi, R. Ranieri Efficacy of a single-dose ondansetron for preventing post-operative nausea and vomiting after laparoscopic cholecystectomy with sevoflurane and remifentanil infusion anaesthesia Eur Rev Med Pharmacol Sci, 5 (2001), pp. 59-63

25 B. Charbit, P. Albaladejo, C. Funck-Brentano, et al. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron Anesthesiology, 102 (2005), pp. 1094-1100

26 F. Roila, A. Del Favero Ondansetron clinical pharmacokinetics Clin Pharmacokinet, 29 (1995), pp. 95-109

27 PL Andrews Physiology of nausea and vomiting Br J Anaesth, 69 (1992), pp. 2S-19S

28 DrugPatentWatch Profile for Brazil Patent: PI0407121 [Internet] [cited 2020 Jun 23]. Available from: DrugPatentWatch, Washington, DC, https://www.drugpatentwatch.com/p/international/index.php?query=BRPI040712 (2020)

29 C.C. Apfel, N. Roewer, K. Korttila How to study postoperative nausea and vomiting Acta Anaesthesiol Scand, 46 (2002), pp. 921-928

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