Adding Lidocaine to Custodiol Mixture

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFayoum University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

patients scheduled for elective Coronary artery bypass grafting surgery

Disqualifiers

Emergency or Redo surgery.

Baseline rhythm other than sinus rhythm

Any degree of heart block, bundle branch block or hemiblock

Known allergy to lidocaine.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine Hydrochloride

    Drug

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

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Custodiol groupActive comparator 1 intervention
Group B: Lidocaine and Custodiol groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

incidence of ventricular fibrillation (VF)

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

Time frame
Perioperative

Secondary outcomes

1

Troponin I (µg/L)

Troponin I to assess myocardial protection between the two cardioplegia solutions used.

Time frame
At immediate postoperatively, 12 and 24 hours postoperative
2

Number of defibrillator shocks

shocks required to terminate ventricular arrhythmia after ACC removal

Time frame
Perioperative
3

Total volume of cardioplegia solution (in ml).

cardioplegia volume given to the patient

Time frame
Perioperative
4

Total cross-clamp time

in minutes

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

Other outcomes

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