Prolonged QTc Interval Clinical Trial
Official title:
Comparative Electrocardiographic Effects of Intravenous Ondansetron and Granisetron in Patients Undergoing Surgery for Carcinoma Breast: A Prospective Single Blind Randomised Trial
Verified date | May 2011 |
Source | Tata Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 70 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - All patients undergoing breast surgery for carcinoma breast. - Patients between ages 18 to 60 years. - ASA I \ II \ III - Patients weight between 40 and 70 kilograms. Exclusion Criteria: - Patient refusing consent - Prophylactic anti emetic drug administration during intraoperative period - Known case of prolonged QTc interval - Known case decompensated cardiomyopathy - Known case of cardiac arrhythmia or bundle branch block - Case of congestive heart failure with left ventricular ejection fraction <40% - Abnormal serum level of potassium, calcium, magnesium |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Hopsital | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration | Both drugs are known to prolong QTc and other ECG intervals | 0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours | Yes |
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