Lidocaine added to Custodiol for heart protection during CABG
Adding Lidocaine to Custodiol® Cardioplegia to Decrease Post-bypass Ventricular Arrhythmias in Adult Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery; A Prospective Randomized Double-Blinded Clinical Trial.
This trial will test whether adding lidocaine to Custodiol reduces ventricular arrhythmias and the need for defibrillation in adults having elective on‑pump coronary artery bypass grafting.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fayoum University Hospital Academic / other |
| Locations | 1 site (Al Fayyum) |
| Trial ID | NCT07205757 on ClinicalTrials.gov |
What this trial studies
This randomized, double‑blind trial will enroll adults scheduled for elective on‑pump CABG and randomize them 1:1 to receive either standard Custodiol cardioplegia or Custodiol with added lidocaine. An anesthesiologist not involved in patient care will prepare the blinded solutions, and the cardioplegia will be given as a single dose per current Custodiol practice. The main outcomes focus on immediate postoperative ventricular arrhythmias and the need for defibrillation after aortic cross‑clamp removal. The trial will follow CONSORT reporting and the Declaration of Helsinki.
Who should consider this trial
Good fit: Ideal candidates are adults in sinus rhythm scheduled for elective on‑pump CABG who do not have prior conduction blocks, significant renal or hepatic impairment, or a lidocaine allergy.
Not a fit: Patients undergoing emergency or redo surgery, those with baseline conduction abnormalities, significant kidney or liver disease, or known lidocaine allergy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding lidocaine could lower the rate of ventricular arrhythmias and reduce the need for defibrillation after cardiopulmonary bypass.
How similar studies have performed: Some observational reports and physiologic rationale support lidocaine's antiarrhythmic effect in cardioplegia, but high‑quality randomized evidence for adding lidocaine to Custodiol is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients scheduled for elective Coronary artery bypass grafting surgery Exclusion Criteria: * Emergency or Redo surgery. * Baseline rhythm other than sinus rhythm * Any degree of heart block, bundle branch block or hemiblock * Known allergy to lidocaine. * Chronic kidney disease. * Hepatic impairment. * Severe psychiatric illness.
Where this trial is running
Al Fayyum
- Fayoum University Hospital — Al Fayyum, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed H Ragab, MD — Lecturer of Anesthesiology
- Study coordinator: Mohamed H Ragab, MD
- Email: mhr02@fayoum.edu.eg
- Phone: 01090050298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.