Evaluating 100 Hz Tetanic Stimulation for Diagnosing Neuromuscular Block
Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study
University of Debrecen · NCT06754995
This study is testing a new way to check if patients have leftover muscle weakness after surgery by using a special electrical stimulation method to see how their muscles respond.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Debrecen (other) |
| Locations | 2 sites (Debrecen, Hajdú-Bihar and 1 other locations) |
| Trial ID | NCT06754995 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using 100 Hz tetanic stimulation with an electromyography device to exclude postoperative residual neuromuscular block in patients. It involves monitoring electric responses from the musculus digiti minimi after supramaximal stimulation of the ulnar nerve. Patients are categorized based on their baseline electroneurographic findings, and the study investigates the development of fatigue during tetanic stimulation in both normal and abnormal ENG groups. The study seeks to establish a 'safety margin' for neuromuscular junction monitoring that is not typically provided by standard methods.
Who should consider this trial
Good fit: Ideal candidates include ASA 1-3 patients with a normal BMI who are in a supine position with one arm accessible.
Not a fit: Patients with impaired neuromuscular function, those on drugs affecting neuromuscular transmission, pregnant or breastfeeding women, and those undergoing acute surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing residual neuromuscular block in patients undergoing anesthesia.
How similar studies have performed: While the approach is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA 1-3; * BMI 18.5-25 (normal body weight); * patient is in supine position with one arm accessible. Exclusion Criteria: * 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
Where this trial is running
Debrecen, Hajdú-Bihar and 1 other locations
- Department of Anesthesiology and Intensive Care, University of Debrecen — Debrecen, Hajdú-Bihar, Hungary (NOT_YET_RECRUITING)
- University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care — Debrecen, Hungary (RECRUITING)
Study contacts
- Study coordinator: Adrienn Pongrácz, MD PhD
- Email: pongadri@gmail.com
- Phone: +36302390132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polyneuropathies, electromyography, electroneurography, tetanic stimulation, residual neuromuscular block, neuromuscular monitoring