N/A
N=60
Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
Residual Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT04352140 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Accuracy of Values Between Tetragraph and ToFscan — 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tetragraph (Device); ToFscan (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Values Between Tetragraph and ToFscan |
0; 2 | — |
| SECONDARY Incidence of Residual Neuromuscular Blockade |
3; 2 | — |
Summary
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.
Eligibility Criteria
Inclusion Criteria
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents 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 or leg into the sterile field
Data sourced from ClinicalTrials.gov (NCT04352140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.