EFFICACY OF GENERIC GRANISETRON VS KYTRIL® FOR PONV IN MAJOR GYNECOLOGICAL OPERATIONS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL

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ALEYASIN ASHRAF; HANAFI SOMAYEH; SAFFARIEH ELHAM; TORKAMANDI HASSAN; ALAHYARI SARA; SADEGHI FARIBORZ; JAVADI MOHAMMADREZA

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Journal: Iranian Journal of Pharmaceutical Research Year:2012 | Volume:11 | Issue:4 Page(s): 1059-1064

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Title

EFFICACY OF GENERIC GRANISETRON VS KYTRIL® FOR PONV IN MAJOR GYNECOLOGICAL OPERATIONS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL

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Keywords

POSTOPERATIVE NAUSEA AND VOMITING (PONV)

GENERIC GRANISETRON

KYTRIL®

GYNAECOLOGICAL SURGERY

Abstract

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 KytrilÒ, 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 KytrilÒ (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 KytrilÒ 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 KytrilÒ. 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 KytrilÒ.

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APA: Copy

ALEYASIN, ASHRAF, HANAFI, SOMAYEH, SAFFARIEH, ELHAM, TORKAMANDI, HASSAN, ALAHYARI, SARA, SADEGHI, FARIBORZ, & JAVADI, MOHAMMADREZA. (2012). EFFICACY OF GENERIC GRANISETRON VS KYTRIL® FOR PONV IN MAJOR GYNECOLOGICAL OPERATIONS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 11(4), 1059-1064. SID. https://sid.ir/paper/288019/en

Vancouver: Copy

ALEYASIN ASHRAF, HANAFI SOMAYEH, SAFFARIEH ELHAM, TORKAMANDI HASSAN, ALAHYARI SARA, SADEGHI FARIBORZ, JAVADI MOHAMMADREZA. EFFICACY OF GENERIC GRANISETRON VS KYTRIL® FOR PONV IN MAJOR GYNECOLOGICAL OPERATIONS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2012;11(4):1059-1064. Available from: https://sid.ir/paper/288019/en

IEEE: Copy

ASHRAF ALEYASIN, SOMAYEH HANAFI, ELHAM SAFFARIEH, HASSAN TORKAMANDI, SARA ALAHYARI, FARIBORZ SADEGHI, and MOHAMMADREZA JAVADI, “EFFICACY OF GENERIC GRANISETRON VS KYTRIL® FOR PONV IN MAJOR GYNECOLOGICAL OPERATIONS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 11, no. 4, pp. 1059–1064, 2012, [Online]. Available: https://sid.ir/paper/288019/en

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