Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve
- Conditions
- Residual Neuromuscular Blockade
- Interventions
- Device: TetraGraph
- Registration Number
- NCT04352127
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients undergoing an elective surgical procedure that requires use of NMBA agents administered intraoperatively.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-dominant hand TetraGraph Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand Dominant hand TetraGraph Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand
- Primary Outcome Measures
Name Time Method Subjective Evaluation to Neurostimulation up to 1 hour postoperatively The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.
- Secondary Outcome Measures
Name Time Method Incidence of Residual Neuromuscular Blockade Up to 1 hour postoperatively Number of subjects with train of four ratio \< 0.9 after administration of reversal agent.
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Florida🇺🇸Jacksonville, Florida, United States