Adding Lidocaine to Custodiol Mixture

NCT07205757 | Recruiting Phase 4

• 1 other identifier: R 751
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

CAD; Arrhythmia Ventricular

Keywords

Custodiol; lidocaine; Bretschneider solution; Ventricular arrythmia

Outcome Measures

Primary Outcomes (1)

• incidence of ventricular fibrillation (VF)

  incidence of VF occurring after Aorta cross-clamp (ACC) removal

  Perioperative

Secondary Outcomes (19)

• Troponin I (µg/L)

  At immediate postoperatively, 12 and 24 hours postoperative

• Number of defibrillator shocks

  Perioperative

• Total volume of cardioplegia solution (in ml).

  Perioperative

• Total cross-clamp time

  from cross clamp until removal of aorta cross clamp up to 6 hours

• total CPB time

  from starting CPB until weaning from bypass is completed up to 6 hours

Study Arms (2)

Custodiol group

ACTIVE COMPARATOR

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

Drug: Custodiol Solution

Lidocaine and Custodiol group

EXPERIMENTAL

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.

Drug: Lidocaine Hydrochloride; Drug: Custodiol Solution

Interventions

Lidocaine Hydrochloride DRUG

6.5 ml of 2% lidocaine (Lidocaine HCL -Sunny Pharmaceutical)

Also known as: Xylocaine

Lidocaine and Custodiol group

Custodiol Solution DRUG

cardioplegia solution will be administered as a single dose of 20 mL/kg over 6-8 minutes at a temperature of 5-8 °C. An additional half dose of the same solution will be prepared and infused if the procedure exceeds 180 minutes after the initial dose is completed.

Also known as: Bretschneider solution, HTK solution

Custodiol group; Lidocaine and Custodiol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for elective Coronary artery bypass grafting surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Egypt

RECRUITING

Related Publications (9)

• Bretschneider HJ, Hubner G, Knoll D, Lohr B, Nordbeck H, Spieckermann PG. Myocardial resistance and tolerance to ischemia: physiological and biochemical basis. J Cardiovasc Surg (Torino). 1975 May-Jun;16(3):241-60.

  PMID: 239002 BACKGROUND

• Barbero C, Pocar M, Marchetto G, Cura Stura E, Calia C, Dalbesio B, Filippini C, Salizzoni S, Boffini M, Rinaldi M, Ricci D. Single-Dose St. Thomas Versus Custodiol(R) Cardioplegia for Right Mini-thoracotomy Mitral Valve Surgery. J Cardiovasc Transl Res. 2023 Feb;16(1):192-198. doi: 10.1007/s12265-022-10296-z. Epub 2022 Aug 8.

  PMID: 35939196 BACKGROUND

• Ferguson ZG, Yarborough DE, Jarvis BL, Sistino JJ. Evidence-based medicine and myocardial protection--where is the evidence? Perfusion. 2015 Jul;30(5):415-22. doi: 10.1177/0267659114551856. Epub 2014 Oct 8.

  PMID: 25298053 BACKGROUND

• Chan J, Oo S, Butt S, Benedetto U, Caputo M, Angelini GD, Vohra HA. Network meta-analysis comparing blood cardioplegia, Del Nido cardioplegia and custodiol cardioplegia in minimally invasive cardiac surgery. Perfusion. 2023 Apr;38(3):464-472. doi: 10.1177/02676591221075522. Epub 2022 Feb 27.

  PMID: 35225070 BACKGROUND

• Ghiragosian C, Harpa M, Stoica A, Sanziana FO, Balau R, Hussein HA, Elena GS, Neagoe RM, Suciu H. Theoretical and Practical Aspects in the Use of Bretschneider Cardioplegia. J Cardiovasc Dev Dis. 2022 Jun 2;9(6):178. doi: 10.3390/jcdd9060178.

  PMID: 35735807 BACKGROUND

• Kantathut N, Luangpatom-Aram K, Khajarern S, Leelayana P, Cherntanomwong P. Comparison of Single-Dose Cardioplegia in Valvular Heart Surgery: Lactated Ringer's-Based del Nido vs. Histidine-Tryptophan-Ketoglutarate Cardioplegia Solution. Braz J Cardiovasc Surg. 2023 Oct 6;38(6):e20220447. doi: 10.21470/1678-9741-2022-0447.

  PMID: 37801520 BACKGROUND

• Duan L, Hu GH, Wang E, Zhang CL, Huang LJ, Duan YY. Del Nido versus HTK cardioplegia for myocardial protection during adult complex valve surgery: a retrospective study. BMC Cardiovasc Disord. 2021 Dec 18;21(1):604. doi: 10.1186/s12872-021-02411-w.

  PMID: 34922443 BACKGROUND

• Hearse DJ, O'Brien K, Braimbridge MV. Protection of the myocardium during ischemic arrest. Dose-response curves for procaine and lignocaine in cardioplegic solutions. J Thorac Cardiovasc Surg. 1981 Jun;81(6):873-9.

  PMID: 7230856 BACKGROUND

• Siddiqi S, Blackstone EH, Bakaeen FG. Bretschneider and del Nido solutions: Are they safe for coronary artery bypass grafting? If so, how should we use them? J Card Surg. 2018 May;33(5):229-234. doi: 10.1111/jocs.13539. Epub 2018 Feb 14.

  PMID: 29444545 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Bretschneider cardioplegic solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohamed H Ragab, MD

  Lecturer of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed H Ragab, MD

CONTACT

01090050298; mhr02@fayoum.edu.eg

Mahdy A Abdelhady, MD

CONTACT

01203632563; maa45@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized into two equal groups (1:1 allocation) using a computer-generated random number that will be enclosed in a sealed opaque envelope opened by an anesthesiologist, who is responsible for preparing the cardioplegia solution outside the OR and will not be involved in patient management or data collection. Patients, cardiothoracic surgeons, anesthesiologists, and data collectors will be blinded to group allocation until the end of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology

Model Details: This randomized double-blinded clinical trial will be reported following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 3, 2025
• Study Start: October 3, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

EG (1)