Efficacy of prophylactic intravenous granisetron in postoperative emesis in adults.
OBJECTIVE
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.


CONCLUSIONS
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.
Hanaoka
Kazuo
K
Department of Anesthesiology, Faculty of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, 113-8655 Tokyo, Japan.
Toyooka
Hidenori
H
Kugimiya
Toyoki
T
Ohashi
Yasuo
Y
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D012702:Serotonin Antagonists / Q000627:therapeutic use*
D017829:Granisetron; D012702:Serotonin Antagonists