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NCT Number: NCT06707532

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

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.

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Key information

Conditions

Kidney Failure, Acute Acute Kidney Injury Arrhythmias, Cardiac Butyrylcholinesterase deficiency Cardiovascular Diseases Chemically-Induced Disorders Chronic Pain Drug-Related Side Effects and Adverse Reactions Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications General Anesthetic Drug Adverse Reaction Heart Arrhythmia Heart Diseases Kidney Diseases Male Urogenital Diseases Muscle Hypotonia Muscle Relaxation Muscular Diseases Musculoskeletal Diseases Myopathy; Drugs Myotoxicity Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Projection Radiation Injuries Renal Insufficiency Signs and Symptoms Succinylcholine Sensitivity Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

Location status: Recruiting

Location contact

Marek Szamborski, MD

CONTACT

[email protected]

698-448-639 ext. +48

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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

Rocuronium

Drug

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: muscular relaxant, general anaesthesia

Primary outcomes

  1. Baseline laboratory parameters and additional tests

    Time frame: up to 24 hours before procedure

    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

  2. During the procedure (before the start of current application)

    Time frame: before the start of current application

    Serum myoglobin Serum troponin Serum CPK

  3. Endline laboratory parameters and additional tests

    Time frame: 12 hours after procedure

    Serum myoglobin Serum troponin Serum CPK Serum creatinine Serum potassium Total morphology evaluation of HGB and PLT values

  4. NRS

    Time frame: Checked before procedure and every 6 hours for the first 24 hours after the procedure

    numerical pain scale 0-10 points

  5. QoR - 15

    Time frame: Administered to the patient before surgery and 24 hours after surgery

    post-operative quality of life and improvement scale 0-150 points

Secondary outcomes

  1. BMI

    Time frame: Before performing procedure

    Body mass index 15-45

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Szamborski, MD

CONTACT

[email protected]

698-448-639 ext. +48

Sponsors and collaborators

Lead sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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