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

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.