Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: a non-inferiority randomized controlled trial
Palonosetrona versus ondansetrona para profilaxia de náuseas e vômitos pós-operatórios em colecistectomia laparoscópica: um ensaio clínico randomizado de não inferioridade
Francisco José Chiaradia Davolos; Norma S. Modolo; Leandro G. Braz; Paulo do Nascimento Junior
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
Resumo
Introdução
Testamos a hipótese de que, dentro da margem de 15% de diferença de risco, a palonosetrona não é inferior à ondansetrona na redução da incidência de náuseas e vômitos pós-operatórios (NVPO) em colecistectomia laparoscópica.
Métodos
Realizamos um estudo duplo-cego, de não inferioridade, randomizado e controlado com 212 pacientes com idades entre 18 e 65 anos submetidos à colecistectomia laparoscópica sob anestesia geral em dois hospitais de atenção secundária. Os pacientes foram randomizados para receber palonosetrona (0,075 mg) ou ondansetrona (8 mg) por via intravenosa na indução da anestesia. Ondansetrona (8 mg) também foi administrada 8 e 16 horas de pós-operatório. Todos os procedimentos anestésicos e cirúrgicos foram padronizados. Os pacientes foram avaliados durante 24 horas de pós-operatório para ocorrência de NVPO.
Resultados
Uma alta incidência de NVPO foi observada 2–6 horas de pós-operatório, com uma taxa de 36,8% (intervalo de confiança [IC] de 95% 28,2–46,3) no grupo palonosetrona, em comparação com 43,4% (IC 95% 34,4–52,9) no grupo ondansetrona. A diferença de risco (IC 95%) entre palonosetrona e ondansetrona para NVPO foi 0 (-10,9 a 10,9) em 0–2 horas, -6,6 (-19,4 a 6,5) em 2–6 horas, -0,9 (-11,0 a 9,2) às 6–12 horas e -2,8 (-9,6 a 3,6) às 12–24 horas. Não houve diferença estatisticamente significativa entre os grupos palonosetrona e ondansetrona no uso de medicação de resgate (dimenidrinato). Não houve eventos adversos associados aos medicamentos em estudo.
Conclusão
A palonosetrona não é inferior à ondansetrona em pacientes com risco de NVPO submetidos à colecistectomia laparoscópica, sendo uma boa opção para profilaxia de NVPO, pois pode ser administrado em dose única.
Palavras-chave
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
Submitted date:
08/04/2020
Accepted date:
06/26/2021
Facebook
Google+
Twitter
LinkedIn
Mendeley
StumbleUpon
CiteULike
Reddit
Email