Effect of amiodarone in postoperative atrial fibrillation after coronary artery bypass surgery

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014090813156N7
• Date of registration: 2014-12-30
• Prospective Registration: No
• Primary sponsor: Research Centre of Mazandaran Univeristy of Medical Sciences
• Public title: Effect of amiodarone in postoperative atrial fibrillation after coronary artery bypass surgery
• Scientific title: Effect of prophylactic amiodarone in the prevention of postoperative atrial fibrillation after coronary artery bypass surgery in Mazandaran Heart Center
• Date of first enrolment: 2014-11-22
• Target sample size: 150
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/13083
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: 2-3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Kaveh Jafari
• Affiliation: Mazandaran University of Medial Sciences

• Name: Kaveh Jafari
• Affiliation: Mazandaran University of Medial Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criterion: preoperative sinus rhythm.
Exclusion criteria: allergy to amiodarone or use of amiodarone in the last 6 months; history of toxicity with amiodarone, anti-arrhythmic therapy before surgery; thyroid disease; aspartate aminotransferase or alanine aminotransferase concentration 4 times higher than normal; pregnant patients, a lower rate 50; heart failure; AV block and surgical history of lung disease and hepatitis.
Exclusion criteria:

Age minimum: no limit
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

CAD in CABG.
Mechanical complication of coronary artery bypass and valve grafts

Mechanical complication of coronary artery bypass and valve grafts

Intervention(s)

Placebo

Amiodarone: Amiodarone vial 2 vials 2 ml ampoules equivalent to 300 mg amiodarone, the surgical incision during a time period of 20 minutes through a central venous catheter, and the next dose as DrIp ICUOH within 24 hours by weight will receive 20 mg per kg.
Preoperative and Postoperative atrial size and ejection fraction measured

Treatment - Drugs

Control group: in this group use placebo (structured by normal saline serum) that similiar to Amiodarone Ampules and tablets. according to this research, anesthesia and patient do not inform about infusion, so two blind research have. in OR; two times infuse placebo and after that in ICU ward infuse drip in 24 hrs, then oral placebo are fed until discharge.
Preoperative and Postoperative atrial size and ejection fraction measured

Intervention 1: Control group: in this group use placebo (structured by normal saline serum) that similiar to Amiodarone Ampules and tablets. according to this research, anesthesia and patient do not inform about infusion, so two blind research have. in OR; two times infuse placebo and after that in ICU ward infuse drip in 24 hrs, then oral placebo are fed until discharge.
Preoperative and Postoperative atrial size and ejection fraction measured. Intervention 2: Amiodarone: Amiodarone vial 2 vials 2 ml ampoules equivalent to 300 mg amiodarone, the surgical incision during a time period of 20 minutes through a central venous catheter, and the next dose as DrIp ICUOH within 24 hours by weight will receive 20 mg per kg.
Preoperative and Postoperative atrial size and ejection fraction measured.

Primary Outcome(s)

The incidence of atrial fibrillation. Timepoint: During hospitalization. Method of measurement: Monitoring.

Secondary Outcome(s)

Hospitalization time. Timepoint: During hospitalization. Method of measurement: Monitoring and documentation.

Source(s) of Monetary Support

Research Centre of Mazandaran Univeristy of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Mazandaran University of Medical Sciences