drugset / Trial / NCT01352130

Granisetron Versus Ondansetron: Comparative Effects on ECG, QTc

NCT01352130

Phase 4 Completed 70 enrolled Tata Memorial Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Postoperative nausea and vomiting \[PONV\] are common and distressing symptoms after surgery performed under general anaesthesia. 5HT3 antagonists are routinely used for prevention as well as treatment of PONV. After IRB approval we compared the effects of ondansetron and granisetron on the various intervals on ECG in 70 patients undergoing elective surgery for carcinoma breast after written informed consent. The demographic data was collected. The administration of the anaesthetic was left to the discretion of the operating room staff specialist. In the Postoperative Recovery Room patients were randomised to receive 8 mgs of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at 0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse rate, Non-invasive blood pressure and SpO2 were also recorded. T

Timeline

Start
2007-03
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Granisetron Other / unclassified 1 mg Intravenous
Comparator Ondansetron Other / unclassified 8 mg Intravenous

Indications

No indication recorded.