SINGLE-DOSE ONDANSETRON FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING - RESULTS FROM THE ITALIAN MULTICENTER ONDANSETRON STUDY

In order to verify the efficacy and safety of a single intravenous dos e of ondansetron in the prevention of postoperative nausea and vomitin g (PONV), 928 patients undergoing ophthalmic, gynaecological, abdomina l and urological procedures under general anaesthesia were enrolled in a single-blind multicentre placebo-controlled study. Patients were ra ndomly allocated to receive either a single intravenous dose of ondans etron 4mg or placebo before the induction of general anaesthesia. Gene ral anaesthesia was induced with thiopental sodium and maintained with fentanyl, nitrous oxide and isoflurane in oxygen. Postoperative analg esia was provided with the administration of morphine and/or ketoprofe n, with similar total amounts being administered to both groups. The p ercentage of patients experiencing PONV was significantly higher in th e placebo group (80 vs 20%; p < 0.001). 69 episodes were reported in t he group treated with ondansetron compared with 227 episodes in the gr oup receiving placebo. In a subgroup of patients with a previous histo ry of PONV, ondansetron administration produced relief from emetic sym ptoms in 75% of the patients, while only 25% of patients administered placebo were symptom-free during the 24 hours of the study. No differe nces were observed in the incidence of adverse events between the 2 gr oups of patients. The results of this study demonstrate that ondansetr on is effective and safe in the prevention of PONV in patients undergo ing a variety of surgical procedures under general anaesthesia.