[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570460":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":65,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":65,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":65,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":91,"overallStatus":48,"whyStopped":65,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"4th Military Clinical Hospital with Polyclinic, Poland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Drug: Propofol",{"label":15,"type":10,"description":16,"interventionNames":17},"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®).",[18],"Drug: Rocuronium",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Propofol","Induction of anaesthesia:\n\n* Fentanyl 1-3ug\u002Fkg\u002Fm.c i.v.\n* Ketamine 50mg i.v.\n* Propofol 1.5-2mg\u002Fkg\u002Fm.c i.v.\n* Rocuronium 5mg (b.w.\\\u003C60kg) 10mg (b.w.\\>60kg) i.v. Precurarisation\n* Chlorucinylcholine 1-1.5mg\u002Fkg\u002Fm.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\u002Fkg\u002Fm.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.",[9],[26,27],"no muscular relaxant","general anaesthesia",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Rocuronium","Induction of anaesthesia:\n\n* Fentanyl 1-3ug\u002Fkg\u002Fm.c i.v.\n* Ketamine 50mg i.v.\n* Propofol 1.5-2mg\u002Fkg\u002Fm.c i.v.\n* Rocuronium 5mg (b.w.\\\u003C60kg) 10mg (b.w.\\>60kg) i.v. Precurarisation\n* Chlorucinylcholine 1-1.5mg\u002Fkg\u002Fm.c i.v. -\\> Intubation\n\nApplication (cycle of 5 pulses with 2000V biphasic alternating current) - during PFA:\n\n\\- rocuronium 0.1-0.3mg\u002Fkg\u002Fm.c i.v. For TOF \\\u003C2\n\nAbolition of neuromuscular blockade:\n\n\\- Atropine 1-1.5mg i.v. + 1-3mg Neostigmine i.v. Or Sugammadex 2-4mg\u002Fkg\u002Fm.c i.v.",[15],[33,27],"muscular relaxant",[35],{"name":36,"affiliation":37,"role":38},"Marek Szamborski, MD","Senior Assistant","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","698-448-639","+48","mszamborski@4wsk.pl",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"4th Military Clinical Hospital with Polyclinic","RECRUITING","Wroclaw","Lower Silesian Voivodeship","50-981","Poland","PL",{"type":55,"coordinates":56},"Point",[57,58],17.03006,51.10286,{"lat":58,"lon":57},[61],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},{"type":38,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Marek Szamborski","Medical Doctor",null,"100570460","the-potential-protective-effect-of-using-muscle-relaxants-during-electroporation-ablation-pfa-100570460",false,"NCT06707532","The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)","The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart","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.","ALL","18 Years","90 Years",{"count":77,"type":78},32,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84,85,86,87,88,89,90],"Kidney Failure, Acute","Myopathy; Drugs","Heart Arrhythmia","Succinylcholine Sensitivity","Muscle Relaxation","General Anesthetic Drug Adverse Reaction","Projection",[92,93,94,95,96,97,98],"electroporation ablation (PFA)","muscle relaxants","rocuronium","chronic pain","acute kidney failure","chronic heart failure","drug protection","2024-11-26",{"date":101,"type":102},"2024-11-27","ACTUAL",{"date":104,"type":102},"2024-08-01",{"date":106,"type":78},"2025-12-01",{"name":5,"class":6},1]