Prophylaxis with oral granisetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a prospective randomized study.

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.