STUDY OBJECTIVES: To evaluate the efficacy and safety of granisetron-droperidol combination for the prevention of postoperative nausea and vomiting (PONV) after middle ear surgery. DESIGN: Prospective, randomized, double-blind study. SETTING:University hospital. PATIENTS: 150 ASA physical statusI patients (108 females, 42 males) scheduled for elective middle ear surgery. INTERVENTIONS: Patients received granisetron 40 micrograms/kg (n = 50), droperidol 20 micrograms/kg (n = 50), or granisetron 40 micrograms/kg plus droperidol 20 micrograms/kg (n = 50) intravenously immediately before induction of anesthesia. MEASUREMENTS AND MAIN RESULTS: A standard general anesthetic technique and postoperative analgesia were used throughout the study. A complete response, defined as no PONV and no need for another rescue antiemetic, from 0 to 3 hours after anesthesia occurred in 78%, 56%, and 94% of patients who had received granisetron, droperidol, and granisetron plus droperidol, respectively. The corresponding incidence between 3 and 24 hours after anesthesia was 80%, 52% and 94%. Thus, a complete response within the first 24-hour postanesthetic period was greater in patients receiving granisetron-droperidol combination than in those receiving granisetron alone or droperidol alone (p < 0.05). No clinically adverse events were observed in any of the groups. CONCLUSIONS: A combination of granisetron and droperidol is more effective than droperidol or granisetron alone for the prevention of PONV after middle ear surgery.
RCT Entities:
STUDY OBJECTIVES: To evaluate the efficacy and safety of granisetron-droperidol combination for the prevention of postoperative nausea and vomiting (PONV) after middle ear surgery. DESIGN: Prospective, randomized, double-blind study. SETTING: University hospital. PATIENTS: 150 ASA physical status I patients (108 females, 42 males) scheduled for elective middle ear surgery. INTERVENTIONS:Patients received granisetron 40 micrograms/kg (n = 50), droperidol 20 micrograms/kg (n = 50), or granisetron 40 micrograms/kg plus droperidol 20 micrograms/kg (n = 50) intravenously immediately before induction of anesthesia. MEASUREMENTS AND MAIN RESULTS: A standard general anesthetic technique and postoperative analgesia were used throughout the study. A complete response, defined as no PONV and no need for another rescue antiemetic, from 0 to 3 hours after anesthesia occurred in 78%, 56%, and 94% of patients who had received granisetron, droperidol, and granisetron plus droperidol, respectively. The corresponding incidence between 3 and 24 hours after anesthesia was 80%, 52% and 94%. Thus, a complete response within the first 24-hour postanesthetic period was greater in patients receiving granisetron-droperidol combination than in those receiving granisetron alone or droperidol alone (p < 0.05). No clinically adverse events were observed in any of the groups. CONCLUSIONS: A combination of granisetron and droperidol is more effective than droperidol or granisetron alone for the prevention of PONV after middle ear surgery.