Clinical trial NCT06707532: The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)
Official title: The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Failure, Acute
Myopathy; Drugs
Heart Arrhythmia
Succinylcholine Sensitivity
Muscle Relaxation
General Anesthetic Drug Adverse Reaction
Projection
Keywords: electroporation ablation (PFA)
muscle relaxants
rocuronium
chronic pain
acute kidney failure
chronic heart failure
drug protection
Lead sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be randomly divided into 2 groups. Group I will consist of patients undergoing general anaesthesia without the use of the muscle relaxant rocuronium during electric current application. 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).
Primary purpose: SCREENING

Brief 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.

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 \[double blind randomisation\].

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline laboratory parameters and additional tests
timeFrame: up to 24 hours before procedure
measure: During the procedure (before the start of current application)
timeFrame: before the start of current application
measure: Endline laboratory parameters and additional tests
timeFrame: 12 hours after procedure
measure: NRS
timeFrame: Checked before procedure and every 6 hours for the first 24 hours after the procedure
measure: QoR - 15
timeFrame: Administered to the patient before surgery and 24 hours after surgery
Secondary outcomes:
measure: BMI
timeFrame: Before performing procedure
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: 4th Military Clinical Hospital with Polyclinic
state: Dolnośląskie
Study officials:
affiliation: Senior Assistant
name: Marek Szamborski, MD
role: PRINCIPAL_INVESTIGATOR
References: