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

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

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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

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

Profilaxia pré-exposição; Fatores de risco; Terapêutica; Náuseas e vômitos pós-operatórios; Antieméticos

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Submitted date:
08/04/2020

Accepted date:
06/26/2021

610803a1a95395458a74ef54 rba Articles
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