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

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthetic Drug Adverse Reaction; Muscle Relaxation; Kidney Failure, Acute; Heart Arrhythmia; Projection; Myopathy; Drugs; Succinylcholine Sensitivity
• Intervention / Treatment: Drug: Propofol; Drug: Rocuronium

Detailed Description

The procedure of electroporation (PFA) is a method of atrial fibrillation ablation introduced in Poland in 2022. A biphasic high voltage current (2000 volts) is applied to the electrode placement site. Local coagulation of the site is followed by myocardial scarring and interruption of the pathological conduction pathway of premature electrical impulses in the heart. The patient, once qualified by the cardiologist for the procedure of electroporation ablation (PFA), will undergo a standard anaesthetic qualification process with assessment of basic demographics, comorbid conditions, medications taken, determination on the surgical risk scale.

Participants will be randomized into 2 groups. Group I will consist of patients undergoing general anaesthesia without the muscle relaxant rocuronium. Group II will consist of patients undergoing general anaesthesia with the muscle relaxant rocuronium. A total of 32 patients were initially planned for the study (16 patients in each of the two groups). Before the procedure, the anaesthetist will be given a sealed envelope by a person unrelated to the project (hospital administration staff) with a randomised method of anaesthesia based on simple randomisation. Before the procedure, each patient will have a transthoracic ultrasound of the heart (TTE). The patient will not know which study group he/she has been assigned to. The operator performing the procedure will not be informed about the type of anaesthesia used [double blind randomisation].

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marek Szamborski, MD; Phone Number: +48 698-448-639; Email: mszamborski@4wsk.pl

Study Locations

• Poland
  • Dolnośląskie
    • Wrocław, Dolnośląskie, Poland, 50-981
      • Recruiting
      • 4th Military Clinical Hospital with Polyclinic
      • Contact: Marek Szamborski, MD; Phone Number: +48 698-448-639; Email: mszamborski@4wsk.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (no muscular relaxant); Group I - 16 patients undergoing general anaesthesia with endotracheal intubation, during the induction of anaesthesia, the patients will be administered a muscle relaxant from the depolarising group (Chlorsuccilin®) for the endotracheal intubation procedure (using precurarisation). This is a method of pharmacologically preventing the muscle fasciculations characteristic of depolarising agents. For this purpose, a low-dose muscle relaxant from the non-depolarising group - (rocuronium, Esmeron®) will be administered just before the actual dose of the depolarising agent. No muscle relaxant will be used during the actual procedure, but the level of muscle relaxation will be continuously monitored through the use of the NMT - TOF % technique (a method of measuring neuromuscular excitability that allows real-time assessment of muscle strength).	Drug: Propofol; 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.; Other Names: no muscular relaxant; general anaesthesia
Active Comparator: Group II (muscular relaxant); Group II -16 patients undergoing general anaesthesia with endotracheal intubation, during the induction of anaesthesia the patients will be administered a muscle relaxant from the depolarising group (rocuronium, Esmeron®) for the endotracheal intubation procedure (using precurarisation). This is a method of pharmacological prevention of muscle fasciculation, characteristic of depolarising agents. For this purpose, a low-dose muscle relaxant from the non-depolarising group (rocuronium, Esmeron®) will be administered just before the actual dose of the depolarising agent. During the procedure itself, the level of relaxation will be continuously monitored by using the NMT - TOF % technique (a method of measuring neuromuscular excitability that allows real-time assessment of muscle strength). During the ablation performed, the patient will be under the influence of a muscle relaxant from the non-depolarising group (rocuronium, Esmeron®).	Drug: Rocuronium; 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.; Other Names: general anaesthesia; muscular relaxant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoR - 15	post-operative quality of life and improvement scale 0-150 points	Administered to the patient before surgery and 24 hours after surgery
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	up to 24 hours before procedure
During the procedure (before the start of current application)	Serum myoglobin Serum troponin Serum CPK	before the start of current application
Endline laboratory parameters and additional tests	Serum myoglobin Serum troponin Serum CPK Serum creatinine Serum potassium Total morphology evaluation of HGB and PLT values	12 hours after procedure
NRS	numerical pain scale 0-10 points	Checked before procedure and every 6 hours for the first 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Body mass index 15-45	Before performing procedure

Collaborators and Investigators

• Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
• Investigators: Principal Investigator: Marek Szamborski, MD, Senior Assistant

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; rocuronium; chronic heart failure; muscle relaxants; acute kidney failure; electroporation ablation (PFA); drug protection
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chemically-Induced Disorders; Acute Kidney Injury; Renal Insufficiency; Drug-Related Side Effects and Adverse Reactions; Arrhythmias, Cardiac; Muscle Hypotonia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium; Anesthetics; Propofol
• Other Study ID Numbers: 4_2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No