Thumb vs Great Toe Recovery

N/ACompletedNCT04312256

Mayo Clinic81 enrolled

Overview

Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Residual Neuromuscular Blockade

Interventions

TetraGraphDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 1 hour postoperatively

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 1 hour postoperatively

Data from ClinicalTrials.gov

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