Adding Lidocaine to Custodiol Cardioplegia to Decrease Post-bypass Ventricular Arrhythmias in Adult Patients Undergoing Coronary Artery Bypass Grafting Surgery

What this Trial Is About

Researchers are studying adult patients undergoing elective Coronary Artery Bypass Grafting (CABG) surgery to compare the effects of adding lidocaine to the Custodiol cardioplegia solution versus using standard Custodiol alone. The trial aims to evaluate whether the addition of lidocaine reduces the incidence of ventricular fibrillation after removal of the aortic cross clamp during heart surgery. This phase 4, randomized, double-blinded clinical trial addresses ongoing debate about the best cardioplegic solutions for myocardial protection and arrhythmia prevention during surgery. Participants are randomly assigned to receive either the standard Custodiol solution or Custodiol mixed with lidocaine. The cardioplegia solution is given as a single dose of 20 mL/kg over 6-8 minutes at a temperature of 5-8°C, with an additional half dose if the surgery exceeds three hours. Lidocaine is added at 6.5 ml of 2% per liter of Custodiol in the experimental group. The solution is delivered via an antegrade approach during cardiopulmonary bypass, with anesthesia and surgical procedures following standard protocols. Defibrillation and medications such as amiodarone are used if ventricular fibrillation occurs after cross clamp removal. Participants undergo preoperative assessments including blood tests, imaging, and heart function evaluations. During surgery, monitoring includes ECG, blood pressure, and blood gas analysis. Researchers track the incidence of ventricular fibrillation, number of defibrillator shocks, heart enzyme levels, cardiac function, and recovery indicators such as ventilation time and hospital stay length. The study lasts through surgery and up to one month postoperatively to assess safety and outcomes. Data are analyzed to compare the two solutions' effects on heart rhythm and recovery.

Adding Lidocaine to Custodiol Mixture