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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-18

Study Completion Date

2021-06-29

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.

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Detailed Description

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Conditions

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Residual Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dominant hand

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

Group Type EXPERIMENTAL

TetraGraph

Intervention Type DEVICE

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.

Non-dominant hand

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

Group Type EXPERIMENTAL

TetraGraph

Intervention Type DEVICE

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.

Interventions

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TetraGraph

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No