Prophylaxis of nausea and vomiting after laparoscopic cholecystectomy with ramosetron: randomised controlled trial.

Abstract

Objective: To evaluate the efficacy and safety of ramosetron (a 5-hydroxytryptamine type 3 receptor antagonist) for the prevention of nausea and vomiting after laparoscopic cholecystectomy.

Design: Prospective, randomised, double-blind, placebo-controlled study.

Setting: University and university-affiliated hospitals, Japan.

Subjects: 100 patients, 65 women and 35 men, who had laparoscopic cholecystectomy.

Interventions: Patients were given either placebo or ramosetron at 3 different doses (0.15 mg, 0.3 mg, 0.6 mg) intravenously at the completion of operation. The general anaesthetic technique and postoperative analgesia were standard.

Main outcome measures: Vomiting and safety were assessed for 0 to 24 hours and 24 to 48 hours after anaesthesia.

Results: The number of patients who had a complete response (no nausea, no retching, no vomiting) during 0 to 24 hours after anaesthesia was 15/25 with placebo, 17/25 with ramosetron 0.15 mg, 23/25 with ramosetron 0.3 mg, and 23/25 with ramosetron 0.6 mg; The corresponding numbers from 24 to 48 hours were 16, 17, 23, and 23. No serious adverse events were observed in any of the groups.

Conclusions: Ramosetron 0.3 mg was the minimum effective dose for preventing postoperative nausea and vomiting during 0 to 48 hours after anaesthesia in patients undergoing laparoscopic cholecystectomy.