ORAL DOLASETRON MESYLATE FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Study Objective: To examine the safety and effectiveness of a range of single oral doses of dolasetron mesylate for the prevention of postop erative nausea and vomiting. Design: Randomized, double-blind, placebo -controlled trial. Setting: 32 hospital. Patients: 789 female ASA phys ical status I, II, and III patients, ages 18 to 60 years, weighing bet ween 45 and 100 hg, scheduled for major gynecologic surgery (including abdominal hysterectomy, gynecologic laparotomy, or vaginal hysterecto my) with general anesthesia. Interventions: 25, 50, 100, or 200 mg ora l doses of dolasetron mesylate or placebo were administered 1 to 2 hou rs before induction of anesthesia. Efficacy was assessed for 24 hours postrecovery by measuring complete response (no emetic episodes, no re scue medication), total response (complete response with no nausea), t ime to first emetic episode or rescue and patient visual analog scale evaluations of nausea severity and satisfaction with antiemetic therap y. Measurements and Main Results: Complete response rates for the 50, 100, and 200 mg dose groups were statistically greater than placebo (p less than or equal to 0.018). Likewise, total response rates were sta tistically greater in the 50, 200, and 200 mg dose groups than in the placebo group (p = 0.012). Percentage of patients with no nausea and p atient satisfaction scores were significantly higher for each dolasetr on dose group than placebo (p less than or equal to 0.047 and p less t han or equal to 0.004, respectively). Efficacy peaked at the 50 mg dos e. The incidence of adverse events was similar in the placebo (30.1%) and dolasetron groups (29.4%). Headache was the most frequent treatmen t-related adverse event, with 2% to 5% incidence across groups. Incide nce of adverse events did not increase with increasing dolasetron dose s. Dose-related decreases in blood pressure at acute time points were not clinically significant. Conclusion: Single oral doses of dolasetro n, administered 1 to 2 hours before induction of anesthesia, are safe and effective for preventing postoperative nausea and vomiting in this patient sample. Maximal antiemetic response runs seen with the 50 mg oral dolasetron dose. (C) 1998 by Elsevier Science Inc.