Background
Granisetron is a first-generation 5-HT3-receptor antagonist that has shown efficacy in preventing
postoperative nausea and vomiting (
PONV). In this randomized double-blind parallel-group clinical trial, we assessed the efficacy of generic
granisetron versus Kytril®, in the prevention of
PONV in patients undergoing
general anesthesia for gynaecological surgeries. Method One hundred and twenty patients who were supposed to undergo major gynaecological surgeries (
myomectomy and
hysterectomy) in Dr. Shariati Teaching Hospital, Tehran, Iran were randomly assigned to either single dose generic
granisetron (40 mcg/kg), or Kytril® (40 mcg/kg) at the end of the surgery. Two episodes of
emetic symptoms (
nausea and
vomiting) were recorded by a gynaecologist who had no knowledge of which treatment each patient had received. This gynaecologist observed the patients at three different intervals: 6, 12 and 18 h post surgery. At the end of the observation period each patient evaluated the satisfaction with the study
drug, and the gynaecologist evaluated sedation of the patients. Results In the generic
granisetron group 47 and 13 patients, and in the Kytril® group 45 and 15 patients underwent
hysterectomy and
myomectomy respectively. No difference was observed between two treatment groups regarding
postoperative nausea and vomiting control during 18 hours after the drugs administration. Also there were no differences in the satisfaction with the study
drug between the generic
granisetron and Kytril®. No difference in sedation scores was observed between two groups. Conclusion Generic
granisetron exerts efficacy against
PONV after gynaecological surgeries which is non-inferior to that of Kytril®.