Lidocaine added to Custodiol for heart protection during CABG
Official title: 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.
Run by Fayoum University Hospital · NCT07205757 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Fayoum University Hospital Academic / other |
| Locations | 1 site (Al Fayyum, Faiyum Governorate) |
| Status | Recruiting |
| Started | October 3, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07205757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Fayoum University Hospital
Al Fayyum, Faiyum Governorate, 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.