Comparing muscle responses for monitoring neuromuscular function after surgery
Comparison of Adductor Pollicis and Abductor Digiti Minimi Muscles (Thumb Vs. Fifth Digit) As Sites for Neuromuscular Monitoring with Electromyography
This study is testing a device to see if it can better monitor muscle function after surgery for patients who have received a specific muscle relaxant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Debrecen Academic / other |
| Locations | 2 sites (Debrecen, Hajdú-Bihar and 1 other locations) |
| Trial ID | NCT06691204 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the TetraGraph device in monitoring two muscle groups, the adductor pollicis and the abductor digiti minimi, to assess neuromuscular blockade and recovery following the use of rocuronium during elective surgeries. It aims to identify differences in muscle sensitivity to neuromuscular blocking agents and reversal agents by measuring electrical activity in these muscles through electromyography. The study addresses challenges in monitoring due to patient positioning and involuntary movements, providing a potentially reliable method for detecting residual neuromuscular blockade in postoperative patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective surgeries that require neuromuscular blocking agents.
Not a fit: Patients with neuromuscular disorders, significant organ dysfunction, or those undergoing surgeries that involve prepping the arm into the sterile field may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection of residual neuromuscular blockade, enhancing patient safety and recovery outcomes after surgery.
How similar studies have performed: While the approach of using electromyography for monitoring neuromuscular function is established, this specific comparison of muscle groups with the TetraGraph device is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> or = 18 years old * Patients willing to participate and provide an informed consent * Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively. Exclusion Criteria: * Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury. * Patients with systemic neuromuscular diseases such as myasthenia gravis. * Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease. * Patients having surgery that would involve prepping the arm into the sterile field. * Patients receiving a rapid sequence induction. * Patients allergic to rocuronium or sugammadex.
Where this trial is running
Debrecen, Hajdú-Bihar and 1 other locations
- University of Debrecen, Department of Anesthesiology and Intensive Care — Debrecen, Hajdú-Bihar, Hungary (Recruiting)
- University of Debrecen, Debrecen, Hajdú-Bihar 4008 — Debrecen, Hungary (Completed)
Study contacts
- Study coordinator: György NAGY, MD
- Email: gynagy1986@gmail.com
- Phone: +36304354064
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.