Y Fujii1, H Tanaka, T Kawasaki. 1. Department of Anesthesiology, University of Tsukuba Institute of Clinical Medicine, 2-1-1 Amakubo, Tsukuba City, Ibaraki 305, Japan.
Abstract
HYPOTHESIS: Laparoscopic cholecystectomy is associated with a relatively high incidence of postoperative nausea and vomiting when no prophylactic antiemetic is given. This study assesses the efficacy and safety of oral granisetron hydrochloride for the prevention of nausea and vomitingafter laparoscopic cholecystectomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled study. SETTING:University teaching hospital. PATIENTS: The study comprised 120 patients, 92 women and 28 men, undergoinglaparoscopic cholecystectomy. INTERVENTIONS: Patients received orally either placebo or granisetron at 3 different doses (1 mg, 2 mg, and 4 mg; n = 30 of each) 60 minutes before surgery. A standard general anesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: Emetic episodes were recorded during the first 24 hours after anesthesia. RESULTS: The incidence of patients who were emesis-free 24 hours after anesthesia was 60% with 1 mg of granisetron (P =.40), 83% with 2 mg of granisetron (P =.01), and 83% with 4 mg of granisetron (P =.01), compared with placebo (53%). No clinically important adverse effects were observed in any of the groups. CONCLUSION: Preoperative oral granisetron in doses higher than 2 mg is effective for the prevention of nausea and vomitingafter laparoscopic cholecystectomy.
RCT Entities:
HYPOTHESIS: Laparoscopic cholecystectomy is associated with a relatively high incidence of postoperative nausea and vomiting when no prophylactic antiemetic is given. This study assesses the efficacy and safety of oral granisetron hydrochloride for the prevention of nausea and vomiting after laparoscopic cholecystectomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled study. SETTING: University teaching hospital. PATIENTS: The study comprised 120 patients, 92 women and 28 men, undergoing laparoscopic cholecystectomy. INTERVENTIONS:Patients received orally either placebo or granisetron at 3 different doses (1 mg, 2 mg, and 4 mg; n = 30 of each) 60 minutes before surgery. A standard general anesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: Emetic episodes were recorded during the first 24 hours after anesthesia. RESULTS: The incidence of patients who were emesis-free 24 hours after anesthesia was 60% with 1 mg of granisetron (P =.40), 83% with 2 mg of granisetron (P =.01), and 83% with 4 mg of granisetron (P =.01), compared with placebo (53%). No clinically important adverse effects were observed in any of the groups. CONCLUSION: Preoperative oral granisetron in doses higher than 2 mg is effective for the prevention of nausea and vomiting after laparoscopic cholecystectomy.