Conditions: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Keywords: cardiopulmonary bypass reperfusion ventricular fibrillation ventricular fibrillation amiodarone lidocaine cardiac surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 342
Healthy volunteers: no

Brief summary:
This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.) Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart after the aortic cross clamp is removed.

Detailed description:
This was a prospective, randomized, double blinded study in which patients undergoing cardiopulmonary bypass with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. Specifically, we will test the hypothesis that amiodarone administration decreases the incidence of ventricular fibrillation, the number of defibrillation attempts and the total energy and current required for defibrillation should ventricular fibrillation occur.

Arms:
arm 1: Lidocaine is a class I (sodium channel block) antiarrhythmic drug. arm 2: Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm) when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles. arm 3: None

Interventions: intervention 1: Lidocaine intervention 2: Amiodarone intervention 3: Placebo
Intervention descriptions: intervention 1: Lidocaine is a class I (sodium channel block) antiarrhythmic drug intervention 2: 300 mg intervention 3: Saline

Protocol document: