Efficacy of prophylactic intravenous granisetron in postoperative emesis in adults

Abstract

Purpose: This randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, and optimal dose of granisetron in the prophylactic control of postoperative nausea and vomiting in patients undergoing gynecologic surgery or cholecystectomy.

Methods: Three-hundred and fifteen patients (age, 20-65 years) received intravenous granisetron (1 mg or 3 mg) or placebo immediately before the end of anesthesia. After treatment, patients were observed for 24 h, and the occurrence of nausea and vomiting was recorded and safety was assessed. The no-vomiting rate, time-to-first vomiting episode, and severity of nausea were recorded.

Results: The no-vomiting rates in patients receiving granisetron 1 mg and 3 mg were significantly higher than that in the placebo group (83.7%, 78.8%, and 57.9%, respectively; P = 0.0004 for 1 mg vs placebo, P = 0.001 for 3 mg). Time-to-first vomiting episode was longer in the granisetron 1-mg and 3-mg groups than in the placebo group (time-to-event analysis, Kaplan-Meier, log-rank test; 83.2%, 80.1%, and 59.1%, respectively; P = 0.0002 and P = 0.0010). The severity of nausea was also less in granisetron-treated patients (25.2%, 11.5%, and 15.4% severe nausea incidence for placebo, granisetron 1 mg, and granisetron 3 mg, respectively; P = 0.00003 and P = 0.002). Fewer rescue medications were required in the two granisetron-treated groups compared with those receiving placebo. Adverse events were similar in all groups. No differences in efficacy or safety were observed between granisetron doses.

Conclusion: Granisetron is well-tolerated and more effective than placebo in the prophylactic control of nausea and vomiting after surgery. This study suggests that the optimum dose of granisetron is 1 mg.