Comparison of ondansetron and droperidol in the prevention of postoperative nausea and vomiting after laparoscopic surgery in women - A randomised, double-blind, placebo-controlled trial

Background: Women undergoing laparoscopic surgery are susceptible to postoperative nausea and vomiting (PONV). Ondansetron and droperidol are useful antiemetics. This study was designed to ascertain primarily the relative difference in efficacy of ondansetron and droperidol and secondarily between these drugs and placebo in the prevention of PONV after laparoscopic surgery. Methods: The prophylactic antiemetic efficacy of ondansetron and droperidol was compared in a prospective, randomised, double-blind, placebo-controlled trial of 439 female inpatients scheduled for laparoscopic surgery. During induction of standardised general anaesthesia the patients received intravenously either ondansetron 8 mg (n=195), droperidol 1.25 mg (n=193) or placebo (n=51). The occurrence of nausea, vomiting, side-effects and the need for rescue antiemetic medication were recorded for 24 h postoperatively. Results: The proportion of patients with nausea was 48%, 50% and 67% in the ondansetron, droperidol and placebo groups, respectively; with a significant difference when both ondansetron (P=0.02) and droperidol (P=0.04) were compared with placebo. Vomiting occurred in 18%, 26% and 37% of the patients in the three groups, respectively (P=0.05 between ondansetron and droperidol, P=0.004 between ondansetron and placebo, P=0.16 between droperidol and placebo). The proportion of patients given rescue medication was 34%, 28% and 49%, respectively (P=0.23 for ondansetron and droperidol, P=0.07 for ondansetron and placebo, P=0.007 for droperidol and placebo). During early recovery the patients treated with ondansetron were significantly more alert than after droperidol. Serious side-effects were not observed. Headache was significantly more common after ondansetron than after droperidol treatment. Conclusions: The efficacy of prophylactic ondansetron and droperidol in reducing postoperative nausea associated with laparoscopic surgery in female inpatients was similar, but ondansetron appeared to be slightly more efficient than droperidol in preventing vomiting. Ondansetron and droperidol were both significantly better than placebo in the prophylaxis of PONV.