Prophylactic intravenous ondansetron in female outpatients undergoing gynaecological surgery: a multicentre dose-comparison study.
The efficacy and safety of prophylactic intravenous ondansetron in preventing postoperative nausea and vomiting was investigated in a randomized, stratified, double-blind, placebo-controlled, dose-comparison study of 580 ASA physical class I and II female outpatients undergoing gynaecological surgery and receiving general anaesthesia. Patients received either ondansetron 1, 4 or 8 mg, or placebo i.v. immediately prior to a standardized technique for induction and maintenance of anaesthesia. All patients were intubated and received nitrous oxide and a narcotic. All doses of ondansetron were significantly more effective than placebo in preventing emesis over the 24 h postoperative period. Ondansetron significantly decreased nausea and emesis scores over 24 h postoperatively without causing sedation. No changes in laboratory parameters (haematology, blood chemistry, and liver enzymes) or vital signs (heart rate, blood pressure, and respiratory rate) were observed. Headache and dizziness were the most common side-effects; however, their incidence was the same as with placebo. Ondansetron was generally well tolerated, as evidenced by an adverse event, laboratory safety, and vital sign profile similar to placebo. Ondansetron 4 mg was found to be the optimal prophylactic i.v. dose for female outpatients over the entire 24 h postoperative period. Higher doses may offer an added benefit in some patients, such as those with a history of nausea and vomiting following general anaesthesia.
Kovac
A
A
University of Kansas Medical Center, Kansas City 66160-7415.
McKenzie
R
R
O'Connor
T
T
Duncalf
D
D
Angel
J
J
Gratz
I
I
Fagraeus
I
I
McLeskey
C
C
Joslyn
A F
AF
D000328:Adult; D000556:Ambulatory Surgical Procedures; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D010535:Laparoscopy; D009325:Nausea / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011183:Postoperative Complications / Q000517:prevention & control*; D011292:Premedication; D011446:Prospective Studies; D012074:Remission Induction; D012449:Safety; D013997:Time Factors; D014839:Vomiting / Q000517:prevention & control*
D010919:Placebos; D017294:Ondansetron