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Thumb vs Great Toe Recovery

Primary Purpose

Residual Neuromuscular Blockade

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TetraGraph

About this trial

This is an interventional other trial for Residual Neuromuscular Blockade focused on measuring Neuromuscular Blockade, Tetragraph, AMG, EMG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dominant Hand and great toe

Arm Description

Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and great toe.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04312256

First Posted

March 16, 2020

Last Updated

November 15, 2021

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04312256

Brief Title

Thumb vs Great Toe Recovery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 18, 2020 (Actual)

Primary Completion Date

January 19, 2021 (Actual)

Study Completion Date

January 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Residual Neuromuscular Blockade

Keywords

Neuromuscular Blockade, Tetragraph, AMG, EMG

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dominant Hand and great toe

Arm Type

Experimental

Arm Description

Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and great toe.

Intervention Type

Device

Intervention Name(s)

TetraGraph

Intervention Description

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.

Primary Outcome Measure Information:

Title

Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles

Description

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

Title

Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles

Description

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 Outcome Measure Information:

Title

Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles

Description

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

Title

Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J.Ross Renew, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Thumb vs Great Toe Recovery

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