Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve

Conditions
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Residual Neuromuscular Blockade

Intervention / Treatment
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* Device: TetraGraph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dominant hand<br>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 | Device: TetraGraph<br>* FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.<br>|
| Experimental: Non-dominant hand<br>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 | Device: TetraGraph<br>* FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Evaluation to Neurostimulation | 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. | up to 1 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Residual Neuromuscular Blockade | Number of subjects with train of four ratio < 0.9 after administration of reversal agent. | Up to 1 hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular Blockade, Tetragraph, AMG, EMG