General Anesthetic Drug Adverse Reaction, Heart Arrhythmia, Kidney Failure, Acute, Muscle Relaxation, Myopathy; Drugs, Projection, Succinylcholine Sensitivity
Conditions
Keywords
electroporation ablation (PFA), muscle relaxants, rocuronium, chronic pain, acute kidney failure, chronic heart failure, drug protection
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.
Detailed description
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 \[double blind randomisation\].
Interventions
DRUGPropofol
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.
DRUGRocuronium
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.
Sponsors
4th Military Clinical Hospital with Polyclinic, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)
Masking description
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 -\[randomisation by double-blinding\].
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline laboratory parameters and additional tests | up to 24 hours before procedure | 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 |
| During the procedure (before the start of current application) | before the start of current application | Serum myoglobin Serum troponin Serum CPK |
| Endline laboratory parameters and additional tests | 12 hours after procedure | Serum myoglobin Serum troponin Serum CPK Serum creatinine Serum potassium Total morphology evaluation of HGB and PLT values |
| NRS | Checked before procedure and every 6 hours for the first 24 hours after the procedure | numerical pain scale 0-10 points |
| QoR - 15 | Administered to the patient before surgery and 24 hours after surgery | post-operative quality of life and improvement scale 0-150 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | Before performing procedure | Body mass index 15-45 |
Countries
Poland
Contacts
Primary ContactMarek Szamborski, MD
Outcome results
None listed