Study objective: To compare the prophylactic administration of ondansetron with droperidol or placebo to determine its effectiveness in reducing postoperative nausea and vomiting after middle ear procedures.
Design: Prospective, randomized, double-blind study.
Setting: Inpatient otolaryngology service at a university medical center.
Patients: 120 ASA physical status I and II patients presenting for elective middle ear surgical procedures.
Interventions: Patients were randomly assigned to receive either placebo (Group 1), ondansetron 4 mg intravenously (IV) (Group 2), or droperidol 25 mcg/kg i.v. (Group 3) 10 minutes before induction of general anesthesia using thiopental 5 mg/kg i.v. with fentanyl 2 mcg/kg i.v. and maintenance anesthesia with isoflurane 1% to 2% end-tidal in a 50% air/oxygen mixture.
Measurements and main results: Total 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 rescue antiemetic administration, also were recorded. Similar assessments were made over the next 24 hours. Intergroup demographic data were similar except that the male to female ratio was higher in the ondansetron group. Stewart scores, reflecting emergence from anesthesia, were higher with ondansetron compared with droperidol. The incidence of nausea was similar between the groups but the severity was less after ondansetron therapy. More patients vomited after placebo than when given either droperidol or ondansetron. No intergroup differences were noted in the use of rescue antiemetics. Twenty-four hours later, more patients who received the placebo drug had nausea or vomited compared with either ondansetron or droperidol.
Conclusions: Ondansetron 4 mg i.v. is as effective as droperidol and better than placebo in preventing nausea and vomiting in patients undergoing middle ear surgery. No cost advantage as determined by lower use of rescue antiemetics or shorter PACU times was noted after the prophylactic administration of ondansetron.