Preoperative oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery.

OBJECTIVE: To evaluate the efficacy and safety of oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery. DESIGN: Prospective, randomised, double-blind, placebo-controlled study. SETTING: University affiliated hospital, Japan. SUBJECTS: 100 women listed for partial or modified radical mastectomy with or without axillary dissection. INTERVENTIONS: Patients were given either placebo or granisetron in three different doses (1 mg, 2 mg, 4 mg) orally 1 hour preoperatively (n = 25 in each group). A standard general anaesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: All episodes of nausea and vomiting during the first 24 hours after anaesthesia. RESULTS: Complete response, defined as no nausea and vomiting and no need for a "rescue" antiemetic, during the first 24 hours after anaesthesia was recorded in 13 (52%) with placebo, 14 (56%) with granisetron 1 mg, 22 (88%) with 2 mg, and 22 (88%) with 4 mg, respectively (p = 0.006, Fisher's exact test). No clinically serious adverse events were seen in any of the groups. CONCLUSION: Preoperative oral granisetron, in doses of more than 2 mg, is effective for the prevention of postoperative nausea and vomiting in women undergoing general anaesthesia for breast surgery.