Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Study Overview
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Brief Summary
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The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.

Official Title
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Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Conditions
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Residual Neuromuscular Blockade

Intervention / Treatment
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* Device: TetraGraph (TG)
* Device: ToFscan (TS)


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. Exclusion Criteria Patients with unilateral 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.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tetragraph (TG)<br>TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand | Device: TetraGraph (TG)<br>* TetraGraph device is a neuromuscular transmission monitor capable of estimating 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 percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.<br>Device: ToFscan (TS)<br>* ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.<br>|
| Active Comparator: ToFscan (TS)<br>ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand | Device: TetraGraph (TG)<br>* TetraGraph device is a neuromuscular transmission monitor capable of estimating 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 percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.<br>Device: ToFscan (TS)<br>* ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Train-of-Four Ratios (TOFR's) | Train-of-four ratios is the ratio of the fourth muscle response to the first one. | baseline, after 5 minutes, after + 10 minutes | 

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