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

NCT ID: NCT06707532

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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 \[double blind randomisation\].

Conditions

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Kidney Failure, Acute Myopathy; Drugs Heart Arrhythmia Succinylcholine Sensitivity Muscle Relaxation General Anesthetic Drug Adverse Reaction Projection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers
Before the procedure, the anaesthetist will be given a sealed envelope by a person unrelated to the project (hospital administrative staff), with a randomised method of anaesthesia based on simple randomisation. Before the procedure, each patient will have a transthoracic cardiac ultrasound (TTE). The patient will not know which study group he/she has been classified into. The operator performing the procedure will not be informed about the type of anaesthesia performed -\[randomisation by double-blinding\].

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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.

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®).

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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no muscular relaxant general anaesthesia muscular relaxant general anaesthesia

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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4th Military Clinical Hospital with Polyclinic, Poland

OTHER

Sponsor Role lead

Responsible Party

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Marek Szamborski

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marek Szamborski, MD

Role: PRINCIPAL_INVESTIGATOR

Senior Assistant

Locations

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4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marek Szamborski, MD

Role: CONTACT

[email protected]
698-448-639 ext. +48

Facility Contacts

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Marek Szamborski, MD

Role: primary

[email protected]
698-448-639 ext. +48

Other Identifiers

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4_2024

Identifier Type: -

Identifier Source: org_study_id