A randomized, double-blind pilot study examining the use of intravenous ondansetron in the prevention of postoperative nausea and vomiting in female inpatients.
OBJECTIVE
To compare the efficacy and safety profiles of intravenous (IV) ondansetron (two 8 mg doses 8 hours apart) and a placebo when used in the prevention of postoperative nausea and emesis (vomiting or retching).


METHODS
Randomized, double-blind, placebo-controlled, parallel, multicenter pilot study.


METHODS
Four university hospitals in the United States.


METHODS
Two hundred seven women scheduled to undergo inpatient surgical procedures during general anesthesia.


METHODS
Patients were randomized to receive, in a double-blind fashion, either two 8 mg doses of IV ondansetron or a placebo. The first study drug dose was administered before induction of anesthesia; the second dose was given 8 hours later. Each study drug dose was admixed with normal saline to 20 ml and administered IV over 2 to 5 minutes. Vital signs were monitored immediately before and 1 minute after completion of the study drug infusion.


RESULTS
For the 24-hour period following operation, 60% of the patients who received ondansetron and 26% of the patients who received the placebo were emesis-free (p < 0.001). Subanalyses based on patients' previous history of general anesthesia indicated that ondansetron was superior to the placebo in preventing emesis regardless of history [66% vs. 33% in patients who had never had general anesthesia or had had no nausea or emesis following previous anesthesia (p = 0.001) and 50% vs. 17% in patients who had nausea or emesis following previous anesthesia (p = 0.005)]. Ondansetron also was superior to the placebo for the prevention of nausea over the 24-hour study period regardless of anesthesia history. Ondansetron was generally well tolerated. The adverse event, vital sign, and clinical laboratory test profiles were similar to those for the placebo. No patient who received ondansetron had untoward changes in central nervous system function, including sedation.


CONCLUSIONS
Prophylactic IV ondansetron appears to be safe and causes a significant reduction in the frequency and severity of postoperative nausea and emesis.
McKenzie
R
R
Department of Anesthesiology, University of Pittsburgh, PA.
Sharifi-Azad
S
S
Dershwitz
M
M
Miguel
R
R
Joslyn
A F
AF
Tantisira
B
B
Rosenblum
F
F
Rosow
C E
CE
Downs
J B
JB
Bowie
J R
JR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000768:Anesthesia, General; D000932:Antiemetics / Q000627:therapeutic use; D004244:Dizziness / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000209:etiology; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D010919:Placebos; D011183:Postoperative Complications / Q000517:prevention & control*; D011292:Premedication; D012449:Safety; D013997:Time Factors; D014839:Vomiting / Q000517:prevention & control*
D000932:Antiemetics; D010919:Placebos; D017294:Ondansetron