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

Официальное название

The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart

Обзор

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.

Подробное описание

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 \[double blind randomisation\].

Вмешательства

• Препарат 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-c
• Препарат 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.

Первичные конечные точки

• Baseline laboratory parameters and additional tests [Срок оценки: up to 24 hours before procedure]
• During the procedure (before the start of current application) [Срок оценки: before the start of current application]
• Endline laboratory parameters and additional tests [Срок оценки: 12 hours after procedure]
• NRS [Срок оценки: Checked before procedure and every 6 hours for the first 24 hours after the procedure]
• QoR - 15 [Срок оценки: Administered to the patient before surgery and 24 hours after surgery]

Вторичные конечные точки (1)

• BMI [Срок оценки: Before performing procedure]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Скрининг

Центры проведения

Польша · 1 центр

• 4th Military Clinical Hospital with Polyclinic — Wroclaw

Идентификаторы

NCT: NCT06707532 · 4_2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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