a study to compare the effectiveness of two drugs (amiodarone and dronedarone) in decreasing/preventing heart rhythm disturbances that occur during heart surgery in patients with ischemic heart disease
Phase 4
Completed
- Conditions
- Health Condition 1: null- Coronary Artery Disease
- Registration Number
- CTRI/2015/02/005549
- Lead Sponsor
- IPGMER Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Modified Parsonnet score: between 0 and 10;
Patients scheduled for off-pump coronary artery bypass grafting
Exclusion Criteria
Female patients;
Modified Parsonnet score 10.5 and more;
Any contraindication or history of allergy to any of the two drugs under study;
Co-morbid conditions like asthma, COPD, diabetes mellitus, chronic renal disease requiring haemodialysis;
Ejection fraction less than 30%;
Left main coronary artery disease;
Left ventricular aneurysm;
Permanent pacing;
Prior valve surgery;
Morbid obesity;
Peripheral arterial disease;
Prolonged corticosteroid use.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of arrhythmiasTimepoint: intra-operative and first 24 hours post-operative period
- Secondary Outcome Measures
Name Time Method maximum ventricular rate during atrial fibrillationTimepoint: intra-operative and first 24 hours post-operative period