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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The Bretschneider solution, also known as Custodiol, has been widely used in open-heart surgery requiring cardiopulmonary bypass (CPB) since its introduction in 1970. Custodiol is widely favored by cardiac surgeons, being administered as a single dose, and is supposed to offer myocardial protection for up to three hours, permitting an uninterrupted surgical time, especially for intricate procedures The literature continues to debate the superiority of custodial and other cardioplegic solutions, such as the Del Nido and St. Thomas solutions, regarding both short-term and long-term outcomes. Clinical trials and daily practice showed that the use of custodial cardioplegic solution is associated with increased incidences of ventricular arrhythmias, and subsequently, the use of a defibrillator after Aortic Cross Clamp (ACC) removal at the end of CPB when compared to other types of cardioplegia solutions .One of the reasons for this difference mentioned in the literature is the lidocaine contained in other types of cardioplegic solutions. Lidocaine acts as a membrane stabilizer by blocking rapid sodium channels in the heart, thus preventing arrhythmias, in addition to its ability to inhibit calcium influx, which is the primary cause of ischemic-reperfusion injury. Based on these data, the investigators hypothesize that the increased incidence of Ventricular arrhythmias with the use of Custodiol compared to other solutions, such as St Thomas and Del Nido, may be attributed to the absence of lidocaine. Although Custodiol contains tryptophan as a membrane-stabilizing component, it may be beneficial to add lidocaine to the Custodiol mixture to decrease the incidence of VF after cross-clamp removal in adult patients undergoing elective CABG.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients scheduled for elective Coronary artery bypass grafting surgery

Locations
Other Locations
Egypt
Fayoum University Hospital
RECRUITING
Al Fayyum
Contact Information
Primary
Mohamed H Ragab, MD
mhr02@fayoum.edu.eg
01090050298
Backup
Mahdy A Abdelhady, MD
maa45@fayoum.edu.eg
01203632563
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Custodiol group
standard Custodiol cardioplegia solution (manufactured by Dr. Franz Köhler Chemie GmbH, Bensheim, Germany), punctured at the injection port with a 10-cc syringe for blinding
Experimental: Lidocaine and Custodiol group
the modified solution prepared by adding 6.5 ml of 2% lidocaine (Lidocaine HCL -Sunny Pharmaceutical) to each 1 L bag of Custodiol (Group L), using a 10-cc syringe.
Sponsors
Leads: Fayoum University Hospital

This content was sourced from clinicaltrials.gov