- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07571395
Median Nerve Electromyography to Monitor Intraoperative Neuromuscular Function
May 4, 2026 updated by: Pongrácz Adrienn
Comparative Examination of Ulnar and Median Nerve Electromyography Examinations to Monitor Intraoperative Neuromuscular Function
The effect of muscle relaxants need to be followed during surgery and before waking up the patient, the anesthesiologist has to make sure that the effect of muscle relaxants is gone.
For this purpose, anesthesiologists use so called objective neurlmuscular monitors.
These monitors stimulate the ulnar nerve in the wrist and examine the evoked muscle response.
The aim of this study is to examine the usability of another nerve in the wrist, the median nerve.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reka Nemes, MD PhD
- Phone Number: +36 30 966 8722
- Email: nemes.reka@med.unideb.hu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients undergoing elective surgery that requires one dose of non-depolarising neuromuscular blocking agent, whose arms are accessible for intraoperative neuromuscular blockade monitoring.
Description
Inclusion Criteria:
- ASA I-III physical status
- elective surgery requiring muscle relaxation
- both arms are available during surgery in the same position for neuromuscular blockade monitoring
- signed informed consent form
Exclusion Criteria:
- neruomuscular disorder in patient history (eg. stroke, myasthenia)
- innervation problem in either arms (eg. carpal tunnel syndrome)
- deformity to either arms (eg. Dupyurten contracture, severe arthritis)
- Severe hepatic or renal insufficiency that affects muscle relaxant pharmacokinetics
- skin lesions at the site of electrode placement
- implanted pacemaker jelenléte
- gravidity
- muscle relaxant needs to be repeated during surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Median nerve examination
Median nerves in the dominant and non-dominant hands are are examined
|
Electromyographic examination of the median and ulnar nerves to monitor intraoperative neuromuscular blockade
|
|
Ulnar nerve examination
Ulnar nerves in the dominant and non-dominant hands are examined
|
Electromyographic examination of the median and ulnar nerves to monitor intraoperative neuromuscular blockade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CMAP
Time Frame: Baseline
|
Comparison of compound muscle action potential amplitudes evoked by median and ulnar nerve stimulation and measured at the thenar
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery time
Time Frame: Perioperative
|
Time from muscle relaxant administration to spontaneous recovery to TOFR>0,9 monitored with median and ulnar nerve stimulation
|
Perioperative
|
|
Onset time
Time Frame: Baseline
|
Time from administration of muscle relaxant to disappearance of twitch response (TOFC0) monitored with median and ulnar nerve stimulation
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bland-Altman analysis of TOFRs
Time Frame: Intraoperative
|
Bland-Altman analysis of TOFRs obtained with medin and ulnar nerve stimulation
|
Intraoperative
|
|
Bland-Altman analysis of TOFCs
Time Frame: Intraoperative
|
Bland-Altman analysis of TOFCs obtained with median and ulnar nerve stimulation
|
Intraoperative
|
|
Bland-Altman analysis of PTCs
Time Frame: Intraoperative
|
Bland-Altman analysis of PTCs obtained with median and ulnar nerve stimulation
|
Intraoperative
|
|
Baseline TOFRs
Time Frame: Baseline
|
Examination of the stability of baseline TOFRs obtained with median and ulnar nerve stabilization
|
Baseline
|
|
Comparison of CMAP amplitudes obtained from dominant and non dominant hands
Time Frame: Baseline
|
Comparison of CMAP amplitudes obtained from dominant and non dominant hands evoked my median and ulnar nerve stimulation
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 27, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
May 4, 2026
First Posted (Actual)
May 6, 2026
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AITT 2026/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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