Kidney Failure, AcuteNCT06707532
The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)
A study testing Propofol and Rocuronium in people with Kidney Failure, Acute and Myopathy; Drugs, run by 4th Military Clinical Hospital with Polyclinic, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Failure, Acute, Myopathy; Drugs, Heart Arrhythmia
- What is being tested?
- Propofol and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
4th Military Clinical Hospital with Polyclinic
Wroclaw, Lower Silesian Voivodeship, 50-981
Marek Szamborski, MD, 698-448-639 ext. +48, mszamborski@4wsk.pl
About this study
Official title: The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart
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.
Read the 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].
- Conditions
- Kidney Failure, Acute, Myopathy; Drugs, Heart Arrhythmia, Succinylcholine Sensitivity, Muscle Relaxation, General Anesthetic Drug Adverse Reaction
- Being tested
- Propofol, Rocuronium
- Keywords
- electroporation ablation (PFA), muscle relaxants, rocuronium, chronic pain, acute kidney failure, chronic heart failure, drug protection
- Medical subject headings
- Acute Kidney Injury, Myotoxicity, Arrhythmias, Cardiac, Butyrylcholinesterase deficiency, Muscle Hypotonia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called no muscular relaxant, general anaesthesia
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.
RocuroniumDrug
Also called muscular relaxant, general anaesthesia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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®). Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 hours before procedure
During the procedure (before the start of current application)
Serum myoglobin Serum troponin Serum CPK
Measured: 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
Measured: 12 hours after procedure
NRS
numerical pain scale 0-10 points
Measured: 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
Measured: Administered to the patient before surgery and 24 hours after surgery
Secondary outcomes (1)
BMI
Body mass index 15-45
Measured: Before performing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Aug 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Szamborski, 4th Military Clinical Hospital with Polyclinic, Poland
- Investigators
- Marek Szamborski, MD, Principal investigator, Senior Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707532
- Sponsor's protocol ID
- 4_2024
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Muscle Relaxants During Electroporation Ablation (PFA) as a Potential Protective Factor Against Damage to Transverse Striated Muscle Tissue and the Heart
- ClinicalTrials.gov ID
- NCT06707532
- Acronym / sponsor ID
- 4_2024
- Conditions
- Kidney Failure, Acute, Myopathy; Drugs, Heart Arrhythmia, Succinylcholine Sensitivity, Muscle Relaxation, General Anesthetic Drug Adverse Reaction
- Keywords
- electroporation ablation (PFA), muscle relaxants, rocuronium, chronic pain, acute kidney failure, chronic heart failure, drug protection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, PolandUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group I (no muscular relaxant) | Active comparator | Drug: PropofolGroup 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). |
| Group II (muscular relaxant) | Active comparator | Drug: RocuroniumGroup 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®). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with requirement for PFA ablation for cardiac indications and ability to provide informed consent for study participation
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: no muscular relaxant, general anaesthesiaInduction 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. | Drug | Group I (no muscular relaxant) |
| RocuroniumAlso: muscular relaxant, general anaesthesiaInduction 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. | Drug | Group II (muscular relaxant) |
Primary outcome
Baseline laboratory parameters and additional tests
Time frame: 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)
Time frame: before the start of current application
Serum myoglobin Serum troponin Serum CPK
Endline laboratory parameters and additional tests
Time frame: 12 hours after procedure
Serum myoglobin Serum troponin Serum CPK Serum creatinine Serum potassium Total morphology evaluation of HGB and PLT values
NRS
Time frame: Checked before procedure and every 6 hours for the first 24 hours after the procedure
numerical pain scale 0-10 points
QoR - 15
Time frame: Administered to the patient before surgery and 24 hours after surgery
post-operative quality of life and improvement scale 0-150 points
1 secondary outcome
BMI
Time frame: Before performing procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marek Szamborski, MD principal investigator
Senior Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Rocuronium in people with Kidney Failure, Acute and Myopathy; Drugs, run by 4th Military Clinical Hospital with Polyclinic, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Szamborski, MD (698-448-639 ext. +48, mszamborski@4wsk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline laboratory parameters and additional tests (time frame: up to 24 hours before procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.