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

NCT06707532 | Recruiting

• 1 other identifier: 4_2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

• QoR - 15

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

  Administered to the patient before surgery and 24 hours after surgery

Secondary Outcomes (1)

• BMI

  Before performing procedure

Study Arms (2)

Group I (no muscular relaxant)

ACTIVE COMPARATOR

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

Group II (muscular relaxant)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: no muscular relaxant, general anaesthesia

Group I (no muscular relaxant)

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.

Also known as: muscular relaxant, general anaesthesia

Group II (muscular relaxant)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland: lead

Study Sites (1)

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Myotoxicity; Arrhythmias, Cardiac; Butyrylcholinesterase deficiency; Muscle Hypotonia; Chronic Pain

Interventions

Propofol; Anesthesia, General; Rocuronium

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Heart Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia; Anesthesia and Analgesia; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Marek Szamborski, MD

  Senior Assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Szamborski, MD

CONTACT

698-448-639; mszamborski@4wsk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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 -\[randomisation by double-blinding\].
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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).

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

PL (1)