Thumb vs Great Toe Recovery

Study Overview
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Brief Summary
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Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.

Official Title
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Comparison of Flexor Hallicus Brevis and Adductor Pollicis as Sites for Neuromuscular Monitoring With Electromyography (Thumb vs Great Toe) After Sugammadex Administration

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 non-depolarizing NMBA agents administered intraoperatively. Patients with planned administration of sugammadex as a neuromuscular blocking reversal agent. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dominant Hand and great toe<br>Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and great toe. | 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 (ECG) electrodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Up to 1 hour postoperatively | 
| Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds. | Up to 1 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Up to 1 hour postoperatively | 
| Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles | The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds. | Up to 1 hour postoperatively | 

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