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A Prospective Randomized Study

Yoshitaka Fujii, MD; Hiroyoshi Tanaka, MD; Tsuneo Kawasaki, MD

Arch Surg. 2001;136:101-104.

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.

From the Departments of Anesthesiology (Drs Fujii and Tanaka) and Surgery (Dr Kawasaki), Toride Kyodo General Hospital, Toride City, Ibaraki, Japan.

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