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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

Comparison of intravenous amiodarone vs. oral dronedarone as prophylaxis of arrhythmias in patients undergoing off-pump coronary artery bypass grafting

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/02/005549
Enrollment
36
Registered
2015-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Coronary Artery Disease

Interventions

Intervention1: Dronedarone: Class III antiarrhythmic
1 tablet (400mg) two times daily orally for 3 days pre-operatively till the morning of surgery and patient monitored till 24 hours post-opeartively Control Intervention1: Amiodarone: Class III antiarr
amiodarone 3 mg/kg intravenously given as a single dose intra-operatively and patient monitored till 24 hours post-opeartively

Sponsors

IPGMER Kolkata
Lead Sponsor
IPGMER Kolkata
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Modified Parsonnet score: between 0 and 10; Patients scheduled for off-pump coronary artery bypass grafting

Exclusion criteria

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.

Design outcomes

Secondary

MeasureTime frame
maximum ventricular rate during atrial fibrillationTimepoint: intra-operative and first 24 hours post-operative period

Primary

MeasureTime frame
incidence of arrhythmiasTimepoint: intra-operative and first 24 hours post-operative period

Countries

India

Contacts

Public ContactDr Anirban Som

IPGMER Kolkata

anupamgoswami1@gmail.com9830297727

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026