ONDANSETRON VERSUS DROPERIDOL OR PLACEBO WHEN GIVEN PROPHYLACTICALLY FOR THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING MIDDLE-EAR PROCEDURES

Study Objective: To compare the prophylactic administration of ondanse tron with droperidol or placebo to determine its effectiveness in redu cing postoperative nausea and vomiting after middle ear procedures. De sign: Prospective, randomized double-blind study. Setting: Inpatient o tolaryngology service at a university medical center. Patients: 120 AS A physical status I and II patients presenting for elective middle ear surgical procedures. Interventions: Patients were randomly assigned t o receive either placebo (Group 1), ondansetron 4 mg intravenously (IV ) (Group 2), or droperidol 25 mcg/kg IV (Group 3) 10 minutes before in duction of general anesthesia using thiopental 5 mg/kg IV with fentany l 2 mcg/kg IV and maintenance anesthesia with isoflurane 1% to 2% end- tidal in a 50% air/oxygen mixture. Measurements and Main Results: Tota l surgical, anesthesia, extubation, and postanesthesia care unit (PACU ) occupancy times were recorded along with anesthesia recovery scores. The incidence and severity of nausea, vomiting, and pain along with r escue antiemetic administration, also were recorded. Similar assessmen ts were made over the next 24 hours. Intergroup demographic data were similar except that the male to female ratio was higher in the ondanse tron group. Stewart scores, reflecting emergence from anesthesia, were higher with ondansetron compared with droperidol. The incidence of na usea was similar between the groups but the severity was less after on dansetron therapy. More patients vomited after placebo than when given either droperidol or ondansetron. No intergroup differences were note d in the use of rescue antiemetics. Twenty-four hours later, more pati ents who received the placebo drug had nausea or vomited compared with either ondansetron or droperidol. Conclusions: Ondansetron 4 mg IV is as effective as droperidol and better than placebo in preventing naus ea and vomiting in patients undergoing middle ear surgery. No cost adv antage as determined by lower use of rescue antiemetics or shorter PAC U times was noted after the prophylactic administration of ondansetron . (C) 1997 by Elsevier Science Inc.