PolyneuropathiesNCT06754995
Diagnostic Feasibility of 100 Hz Tetanic Stimulation
An observational study of Polyneuropathies, run by University of Debrecen at 2 sites in Hungary.
Trial summary
The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyneuropathies
- How many people
- 40 participants
- Where
- 2 sitesHungary
- Study dates
- 6 Jan 2025to 31 Dec 2027
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical patients
Who may be able to join
- ASA 1-3;
- BMI 18.5-25 (normal body weight);
- patient is in supine position with one arm accessible.
Who cannot join
- diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);
- drugs affecting neuromuscular function (magnesium, aminoglycosides);
- pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);
- breast-feeding;
- acute surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites, 2 recruiting
- Not yet recruiting
Department of Anesthesiology and Intensive Care, University of Debrecen
Debrecen, Hajdú-Bihar, 4032
Adrienn Pongrácz, MD PhD, +36302390132, pongadri@gmail.com
Réka Nemes, MD PhD, +36309668722, reka.nemes.11@gmail.com
- Recruiting
University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care
Debrecen, 4032
About this study
Official title: Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study
The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.
Read the detailed description
The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.
The clinical utilities of the study results are:
- Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring.
- To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.
- Conditions
- Polyneuropathies
- Keywords
- electromyography, electroneurography, tetanic stimulation, residual neuromuscular block, neuromuscular monitoring
- Medical subject headings
- Polyneuropathies, Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal ENG | Patients who have normal results at baseline electroneurogrphy examination | |
| Abnormal ENG | Patients who have abnormal results at baseline electroneurogrphy examination due to polyneuropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
Electroneurography response of the abductor digiti minimi muscle to 100 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.
Measured: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Secondary outcomes (1)
Diagnostic feasibility of electromyography in the examination of safety margin
To see whether tetanic stimulation with electromyography can be used as a routine tool to examine the safety margin and residual neuromuscular block. It is expected that there will be no fade in muscle response to 60 Hz tetanic stimulation in either groups. It is suspected that there will be no tetanic fade response to 100 Hz tetanic stimulation in patinets with normal ENG, however patinets with abnormal baseline ENG will produce tetanic fade. The incidence and extent of tetanic fade response will be examined.
Measured: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start6 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pongrácz Adrienn, University of Debrecen
- Investigators
- Béla Fülesdi, MD PhD DSci, Study director, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754995
- Sponsor's protocol ID
- AITT 2024/2
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study
- ClinicalTrials.gov ID
- NCT06754995
- Acronym / sponsor ID
- AITT 2024/2
- Conditions
- Polyneuropathies
- Keywords
- electromyography, electroneurography, tetanic stimulation, residual neuromuscular block, neuromuscular monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jan 2025 (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 goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.
Detailed description
The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.
The clinical utilities of the study results are:
- Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring.
- To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal ENG | – | –Patients who have normal results at baseline electroneurogrphy examination |
| Abnormal ENG | – | –Patients who have abnormal results at baseline electroneurogrphy examination due to polyneuropathy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients
Key inclusion criteria (3 listed)
- ASA 1-3;
- BMI 18.5-25 (normal body weight);
- patient is in supine position with one arm accessible.
Key exclusion criteria (5 listed)
- diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);
- drugs affecting neuromuscular function (magnesium, aminoglycosides);
- pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);
- breast-feeding;
- acute surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
Time frame: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Electroneurography response of the abductor digiti minimi muscle to 100 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.
1 secondary outcome
Diagnostic feasibility of electromyography in the examination of safety margin
Time frame: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
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 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Béla Fülesdi, MD PhD DSci study director
University of Debrecen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyneuropathies, run by University of Debrecen at 2 sites in Hungary.
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 3 inclusion and 5 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 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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 Adrienn Pongrácz, MD PhD (+36302390132, pongadri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG (time frame: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.). 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 Mar 2025.