RecruitingNot ApplicableNCT06707532

The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)

The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart

Sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Enrollment

32 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Arrhythmia Kidney Failure, Acute Myopathy; Drugs Succinylcholine Sensitivity Muscle Relaxation General Anesthetic Drug Adverse Reaction Projection

Summary

The study aims to improve the safety of the electroporation ablation (PFA) procedure by using muscle relaxants to reduce skeletal muscle damage during the procedure. It will also assess myocardial damage to improve the procedure's quality and speed up recovery after the procedure.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving muscle relaxant medications during pulsed field ablation (PFA) — a catheter-based heart procedure that uses electrical pulses to treat abnormal heart rhythms — can reduce muscle contractions and improve patient comfort and safety. **You may be eligible if...** - You are scheduled to undergo pulsed field ablation (PFA) for a heart rhythm disorder - You can provide informed consent **You may NOT be eligible if...** - You have a known allergy to the general anesthetics used in the procedure - You have a genetic neuromuscular disease such as Duchenne muscular dystrophy or myasthenia gravis - You are unwilling to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol

Induction of anaesthesia: * Fentanyl 1-3ug/kg/m.c i.v. * Ketamine 50mg i.v. * Propofol 1.5-2mg/kg/m.c i.v. * Rocuronium 5mg (b.w.\<60kg) 10mg (b.w.\>60kg) i.v. Precurarisation * Chlorucinylcholine 1-1.5mg/kg/m.c i.v. -\> Intubation Application (cycle of 5 pulses with 2000V biphasic alternating current) - during PFA: \- In case of ventilatory distress pPeak \>30 cm H2O ad hoc Propofol 0.25-0.75mg/kg/m.c i.v. Elimination of neuromuscular blockade: \- To exclude residual relaxation after pre-curative: 1mg Atropine i.v. + 0.5mg Neostigmine i.v.

DRUGRocuronium

Induction of anaesthesia: * Fentanyl 1-3ug/kg/m.c i.v. * Ketamine 50mg i.v. * Propofol 1.5-2mg/kg/m.c i.v. * Rocuronium 5mg (b.w.\<60kg) 10mg (b.w.\>60kg) i.v. Precurarisation * Chlorucinylcholine 1-1.5mg/kg/m.c i.v. -\> Intubation Application (cycle of 5 pulses with 2000V biphasic alternating current) - during PFA: \- rocuronium 0.1-0.3mg/kg/m.c i.v. For TOF \<2 Abolition of neuromuscular blockade: \- Atropine 1-1.5mg i.v. + 1-3mg Neostigmine i.v. Or Sugammadex 2-4mg/kg/m.c i.v.