NCT07205757 Adding Lidocaine to Custodiol Mixture
| NCT ID | NCT07205757 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fayoum University Hospital |
| Condition | CAD |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2025-10-03 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Mohamed H Ragab, MD
PRINCIPAL INVESTIGATOR
Lecturer of Anesthesiology
Frequently Asked Questions
Who can join the NCT07205757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CAD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07205757 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07205757 currently recruiting?
Yes, NCT07205757 is actively recruiting participants. Contact the research team at mhr02@fayoum.edu.eg for enrollment information.
Where is the NCT07205757 trial being conducted?
This trial is being conducted at Al Fayyum, Egypt.
Who is sponsoring the NCT07205757 clinical trial?
NCT07205757 is sponsored by Fayoum University Hospital. The principal investigator is Mohamed H Ragab, MD at Lecturer of Anesthesiology. The trial plans to enroll 70 participants.