Actively Recruiting
The Use of Muscle Relaxants During Electroporation Ablation (PFA) to Protect Muscle and Heart Tissue
Led by 4th Military Clinical Hospital with Polyclinic, Poland · Updated on 2024-11-27
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of muscle relaxants during electroporation ablation (PFA) to reduce skeletal muscle damage and heart muscle injury in patients undergoing this procedure for atrial fibrillation. The study aims to improve the safety and quality of PFA by assessing muscle and heart damage and speeding recovery after the procedure. This trial uses a randomized, double-blind design with adult participants qualified for PFA. Participants are randomly assigned to one of two groups. Group I receives general anesthesia with muscle relaxants only for intubation but not during the actual ablation procedure, while Group II receives muscle relaxants during both intubation and the ablation. Both groups undergo general anesthesia with specific drug protocols including Propofol, Fentanyl, Ketamine, Rocuronium, and Chlorucinylcholine. Muscle relaxation levels are continuously monitored in both groups using neuromuscular excitability techniques. Before the procedure, patients have an ultrasound evaluation of the heart and baseline laboratory tests. During and after the procedure, various measurements are taken including lab tests up to 12 hours post-procedure, pain scores every 6 hours for 24 hours, and quality of recovery questionnaires before and after surgery. The study carefully monitors muscle and heart damage markers and tracks patient recovery to assess the potential protective effect of muscle relaxants during PFA.
CONDITIONS
Brief Title
The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients requiring PFA ablation for heart conditions
- Ability to provide informed consent for study participation
You will not qualify if you...
- Allergy to any general anesthetic drugs used in the study
- Genetic neuromuscular diseases such as Duchenne dystrophy or myasthenia gravis
- Patients who do not provide informed consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo electroporation ablation (PFA) under general anesthesia with or without muscle relaxants. The procedure includes anesthesia induction, ablation with a high voltage current, and neuromuscular monitoring throughout the procedure.
1 procedure visit (in-person)
Duration - 24 hours post-procedure
Participants are monitored for recovery including pain assessment and quality of recovery measures during the first 24 hours after the procedure.
Visits for assessments every 6 hours for 24 hours
Trial Site Locations
Total: 1 location
1
4th Military Clinical Hospital with Polyclinic
Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
Actively Recruiting
Research Team
M
Marek Szamborski, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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