• Clin Drug Investig · Jan 2006

    Randomized Controlled Trial

    Efficacy of granisetron for the treatment of postoperative nausea and vomiting in women undergoing breast surgery: a randomised, double-blind, placebo-controlled trial.

    • Yoshitaka Fujii and Hiroyoshi Tanaka.
    • Department of Anaesthesiology, Toride Kyodo General Hospital, Toride City, Ibaraki, Japan. yfujii@med.toho-u.ac.jp
    • Clin Drug Investig. 2006 Jan 1;26(4):203-8.

    BackgroundWomen undergoing general anaesthesia for breast surgery are especially at risk of experiencing postoperative nausea and vomiting (PONV). This study was undertaken to assess the efficacy of granisetron, a selective serotonin type 3 receptor antagonist, for the treatment of postoperative nausea and vomiting after breast surgery.Design And MethodsThis was a prospective, randomised, double-blind, placebo-controlled study carried out in a university-affiliated teaching hospital. The study included women who experienced nausea lasting >10 minutes and/or vomiting during the first 3 hours after recovery from anaesthesia for breast surgery. Patients intravenously received either placebo or granisetron at four different doses (10 microg/kg, 20 microg/kg, 40 microg/kg and 80 microg/kg). Patients were observed for 24 hours after administration of the study drug.Main Outcome Measures And ResultsA total of 100 women were enrolled in this study. Complete control of established PONV, defined as no emetic symptoms and no need for a rescue antiemetic, was observed in 50% of women receiving granisetron 10 microg/kg (p = 0.5 vs placebo), 85% of women receiving granisetron 20 microg/kg (p = 0.009 vs placebo), 90% of women receiving granisetron 40 microg/kg (p = 0.003 vs placebo), and 85% of women receiving granisetron 80 microg/kg (p = 0.009 vs placebo), compared with 45% of placebo recipients. The efficacies of granisetron 20 microg/kg, granisetron 40 microg/kg, and granisetron 80 microg/kg for the treatment of established PONV were superior to that of granisetron 10 microg/kg (all p < 0.05). No serious adverse effects were observed in any group.ConclusionThe minimum effective dose of granisetron for the treatment of PONV in women undergoing breast surgery was 20 microg/kg. Increasing the granisetron dose to 80 microg/kg provided no further benefit.

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