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

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

Inclusion Criteria1

  • Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation

Exclusion Criteria1

  • Patients with allergies to the general anaesthetics used, genetic diseases of the neuromuscular plateau - e.g. Duchenne dystrophy, myasthenia gravis - and patients who do not gived informed consent to participate in the study will be excluded from the study.

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.


Locations(1)

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, Poland

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NCT06707532


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