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.
Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation
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.
Parallel
Propofol
DrugInduction 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.
Rocuronium
DrugInduction 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.
Baseline laboratory parameters and additional tests
Serum creatinine Serum potassium General morphology evaluation of HGB and PLT values Assessment of QoR-15 Measurement of heart size and mass on TTE ultrasound
During the procedure (before the start of current application)
Serum myoglobin Serum troponin Serum CPK
Endline laboratory parameters and additional tests
Serum myoglobin Serum troponin Serum CPK Serum creatinine Serum potassium Total morphology evaluation of HGB and PLT values
NRS
numerical pain scale 0-10 points
BMI
Body mass index 15-45
Click on the lead sponsor to view all of their trials.
