RESUMEN
PURPOSE: Post-operative nausea and vomiting (PONV) is considered as one of the most disturbing sequels of surgeries under general anesthesia, which if not controlled appropriately increases post-operative morbidity, nursing burden, and general healthcare costs. In this study, we compared granisetron with its brand Kytril(®) and also with metoclopramide regarding PONV management. METHODS: A total of 180 obstetrics and gynecology patients who underwent surgeries under general anesthesia participated in this prospective study at the Dr. Shariati Teaching Hospital, Tehran, Iran. The patients were randomly assigned to single-dose generic granisetron (40 mcg/kg), Kytril(®) (40 mcg/kg), or metoclopramide (0.2 mg/kg) at the end of the surgery. Two episodes of emetic symptoms (nausea and vomiting) were recorded by a gynecologist who had no knowledge of which treatment each patient had received. This gynecologist observed the patients at three different intervals: 0-6, 6-12, and 12-18 h post-surgery. RESULTS: One hundred and thirty-seven patients (76.1 %) underwent hysterectomy and 40 patients (22.2 %) underwent myomectomy. Each group consisted of 60 patients (33 %). The incidence of vomiting in the first 6, 12, and 18 h post-surgery was 22, 15.2, and 13.3 % for granisetron; 18.6, 10, and 8.3 % for Kytril; and 22, 11.9, and 5 % for generic metoclopramide, respectively. There was no significant difference in the incidence of PONV with any of these agents. CONCLUSIONS: All three anti-nausea and vomiting agents, granisetron, its brand (Kytril), and generic metoclopramide, have a similar effect to manage PONV in obstetrics and gynecological surgeries. Trial registration This trial is registered with www.irct.ir, number IRCT201010134927N1.
RESUMEN
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®.