Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-28 @ 4:03 PM
Study NCT ID:
NCT06707532
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D000081030', 'term': 'Myotoxicity'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'C537417', 'term': 'Butyrylcholinesterase deficiency'}, {'id': 'D009123', 'term': 'Muscle Hypotonia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': '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\\].'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline laboratory parameters and additional tests', 'timeFrame': 'up to 24 hours before procedure', 'description': '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'}, {'measure': 'During the procedure (before the start of current application)', 'timeFrame': 'before the start of current application', 'description': 'Serum myoglobin Serum troponin Serum CPK'}, {'measure': 'Endline laboratory parameters and additional tests', 'timeFrame': '12 hours after procedure', 'description': 'Serum myoglobin Serum troponin Serum CPK Serum creatinine Serum potassium Total morphology evaluation of HGB and PLT values'}, {'measure': 'NRS', 'timeFrame': 'Checked before procedure and every 6 hours for the first 24 hours after the procedure', 'description': 'numerical pain scale 0-10 points'}, {'measure': 'QoR - 15', 'timeFrame': 'Administered to the patient before surgery and 24 hours after surgery', 'description': 'post-operative quality of life and improvement scale 0-150 points'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Before performing procedure', 'description': 'Body mass index 15-45'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electroporation ablation (PFA)', 'muscle relaxants', 'rocuronium', 'chronic pain', 'acute kidney failure', 'chronic heart failure', 'drug protection'], 'conditions': ['Kidney Failure, Acute', 'Myopathy; Drugs', 'Heart Arrhythmia', 'Succinylcholine Sensitivity', 'Muscle Relaxation', 'General Anesthetic Drug Adverse Reaction', 'Projection']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nParticipants 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\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT06707532', 'briefTitle': 'The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)', 'organization': {'class': 'OTHER', 'fullName': '4th Military Clinical Hospital with Polyclinic, Poland'}, 'officialTitle': 'The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart', 'orgStudyIdInfo': {'id': '4_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (no muscular relaxant)', 'description': '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).', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (muscular relaxant)', 'description': '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®).', 'interventionNames': ['Drug: Rocuronium']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['no muscular relaxant', 'general anaesthesia'], 'description': 'Induction of anaesthesia:\n\n* Fentanyl 1-3ug/kg/m.c i.v.\n* Ketamine 50mg i.v.\n* Propofol 1.5-2mg/kg/m.c i.v.\n* Rocuronium 5mg (b.w.\\<60kg) 10mg (b.w.\\>60kg) i.v. Precurarisation\n* Chlorucinylcholine 1-1.5mg/kg/m.c i.v. -\\> Intubation\n\nApplication (cycle of 5 pulses with 2000V biphasic alternating current) - during PFA:\n\n\\- In case of ventilatory distress pPeak \\>30 cm H2O ad hoc Propofol 0.25-0.75mg/kg/m.c i.v.\n\nElimination of neuromuscular blockade:\n\n\\- To exclude residual relaxation after pre-curative: 1mg Atropine i.v. + 0.5mg Neostigmine i.v.', 'armGroupLabels': ['Group I (no muscular relaxant)']}, {'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['muscular relaxant', 'general anaesthesia'], 'description': 'Induction of anaesthesia:\n\n* Fentanyl 1-3ug/kg/m.c i.v.\n* Ketamine 50mg i.v.\n* Propofol 1.5-2mg/kg/m.c i.v.\n* Rocuronium 5mg (b.w.\\<60kg) 10mg (b.w.\\>60kg) i.v. Precurarisation\n* Chlorucinylcholine 1-1.5mg/kg/m.c i.v. -\\> Intubation\n\nApplication (cycle of 5 pulses with 2000V biphasic alternating current) - during PFA:\n\n\\- rocuronium 0.1-0.3mg/kg/m.c i.v. For TOF \\<2\n\nAbolition of neuromuscular blockade:\n\n\\- Atropine 1-1.5mg i.v. + 1-3mg Neostigmine i.v. Or Sugammadex 2-4mg/kg/m.c i.v.', 'armGroupLabels': ['Group II (muscular relaxant)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-981', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marek Szamborski, MD', 'role': 'CONTACT', 'email': 'mszamborski@4wsk.pl', 'phone': '698-448-639', 'phoneExt': '+48'}], 'facility': '4th Military Clinical Hospital with Polyclinic', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Marek Szamborski, MD', 'role': 'CONTACT', 'email': 'mszamborski@4wsk.pl', 'phone': '698-448-639', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Marek Szamborski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Assistant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '4th Military Clinical Hospital with Polyclinic, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Marek Szamborski', 'investigatorAffiliation': '4th Military Clinical Hospital with Polyclinic, Poland'}}}}