Publicação: Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting in laparoscopic cholecystectomy: a non-inferiority randomized controlled trial
Carregando...
Data
Orientador
Coorientador
Pós-graduação
Curso de graduação
Título da Revista
ISSN da Revista
Título de Volume
Editor
Tipo
Artigo
Direito de acesso
Resumo
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.
Descrição
Palavras-chave
Antiemetics, Postoperative nausea and vomiting, Pre-exposure prophylaxis, Risk factors, Therapeutics
Idioma
Inglês
Como citar
Brazilian Journal of Anesthesiology (English Edition).
