Thumb vs Great Toe Recovery

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

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

Study Overview

• Status: Completed
• Conditions: Residual Neuromuscular Blockade
• Intervention / Treatment: Device: TetraGraph

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: J.Ross Renew, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): January 19, 2021
• Study Completion (Actual): January 19, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: EMG; Neuromuscular Blockade; Tetragraph; AMG
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 19-011705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes