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

Mayo Clinic

Status: Completed

Conditions: Residual Neuromuscular Blockade

Treatments: Device: TetraGraph

Study type: Interventional

Funder types: Other

Identifiers

NCT04352127

20-000619

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Dominant hand

Experimental group

Description:

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

Treatment:

Device: TetraGraph

Non-dominant hand

Experimental group

Description:

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

Treatment:

Device: TetraGraph