Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07205757

Adding Lidocaine to Custodiol Mixture

Led by Fayoum University Hospital · Updated on 2025-11-17

70

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Adding Lidocaine to Custodiol Mixture

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective Coronary Artery Bypass Grafting surgery
Not Eligible

You will not qualify if you...

  • Emergency or redo surgery
  • Baseline heart 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fayoum University Hospital

Al Fayyum, Egypt

Actively Recruiting

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Research Team

M

Mohamed H Ragab, MD

CONTACT

M

Mahdy A Abdelhady, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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