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The study of Amiodarone infusion given before surgery and its effect on ECHO change and free from irregular heart rate at discharge

Effect of Prophylactic Amiodarone Infusion on Left Atrial Strain and Proportion of Arrhythmia Free Patients at discharge in Adults undergoing Elective Mitral Valve Replacement surgery – A Randomized, Double-blinded, Placebo control trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057651
Enrollment
134
Registered
2023-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: I059- Rheumatic mitral valve disease, unspecified

Interventions

Intervention1: Prophylactic Amiodarone Infusion: At the time of heparinisation during pre-cardiopulmonary bypass, Patient in Intervention arm (Group 2) will receive intravenous infusion of Amiodarone

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elective Mitral valve replacement surgery will be included in this study

Exclusion criteria

Exclusion criteria: Pregnant patients Patients with Thyroid disease Patients with Heart rate of Patients with NYHA IV Patients allergic to Amiodarone Patients with Sick sinus rhythm Patients with Atrioventricular block Patients with Elevated liver enzyme levels Patients with Serum creatinine >2 mg/dl Receiving one or more of the following drugs: cimetidine, phenytoin, cholestyramine, and cyclosporine Patients with Coronary artery disease H/O Previous cardiac surgery Patients with congenital heart diseases Patients with LVEF Systemic hypertension Chronic lung disease

Design outcomes

Primary

MeasureTime frame
To compare the changes in Left atrial strain (LAS) and Proportion of Arrhythmia Free Patients at discharge between the groupsTimepoint: 7 days—

Secondary

MeasureTime frame
1) To compare the proportion of patients with NSR at aortic cross clamp (ACC) release between the groups (number of patients with NSR and number of patients with AF) 2) To compare the conversion of AF to NSR without the need for synchronised cardioversion/Defibrillation after release of ACC between the groups 3) To compare the required energy and number of attempts of synchronised cardioversion/Defibrillation after release of ACC between the groups 4) To compare the need for temporary pacing between the groups 5) To compare the right ventricular systolic pressure (RVSP) and Pulmonary capillary wedge pressure (PCWP) between the groups 6) To compare the duration of postoperative mechanical ventilation between the groups Timepoint: 7 days—

Countries

India

Contacts

Public ContactRaja subramaniyan

Jawaharlal Institute of Postgraduate Medical Education and Research

dr.chitrarajeswari@gmail.com9585887311

Outcome results

None listed

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