• P Diemunsch, A D'Hollander, L Paxton, P Schoeffler, P Wessel, S Navé, R A Brown, and W F Hahne.
• Department of Anesthesiology, Les Hôpitaux Universitaires de Strasbourg, France.
• J Clin Anesth. 1997 Aug 1;9(5):365-73.

Study ObjectiveTo evaluate a range of doses of intravenous (i.v.) dolasetron mesilate, in preventing postoperative nausea and vomiting (PONV).DesignDouble-blind, placebo-controlled, randomized, multicenter trial.SettingTen hospitals and/or surgical centers.Patients281 women undergoing gynecologic surgery with general anesthesia.InterventionsPatients received one of four single, i.v. doses of dolasetron mesilate (12.5 mg, 25 mg, 50 mg, and 100 mg) or placebo administered following cessation of anesthesia.Measurements And Main ResultsPatients were monitored for 24 hours following study drug administration. The antiemetic efficacy of each dolasetron mesilate dose was evaluated by recording the number and timing of emetic episodes, and the effects on nausea were assessed by use of visual analog scales (VAS). Safety was assessed by adverse event reports, clinical laboratory tests, electrocardiographic (ECG) measurements, and monitoring vital signs. Complete responses (patients with no emetic episodes and no escape antiemetic medication requirements in 24 hours) were achieved by 54% in the 12.5-mg, 67% in the 25-mg, and 59% in both the 50-mg and 100-mg dolasetron mesilate dose groups, and by 43% in the placebo group. Nausea VAS assessments demonstrated that dolasetron-treated patients were significantly (p = 0.048) more likely to report no nausea (VAS score < 5 mm) than those in the placebo group. Adverse events reported generally were mild in intensity, and there were no clinically significant changes in laboratory tests, vital signs, or ECG parameters.ConclusionsDolasetron was effective and well tolerated for the prevention of PONV in female patients undergoing gynecologic surgery with general anesthesia.

32 keywords...

hide…