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

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 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

Sites / Locations

Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dominant hand

Non-dominant hand

Arm 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

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

Outcomes

Primary Outcome Measures

Subjective Evaluation to Neurostimulation

The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.

Secondary Outcome Measures

Incidence of Residual Neuromuscular Blockade

Number of subjects with train of four ratio < 0.9 after administration of reversal agent.

Full Information

NCT ID

NCT04352127

First Posted

April 16, 2020

Last Updated

October 18, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04352127

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 18, 2020 (Actual)

Primary Completion Date

June 29, 2021 (Actual)

Study Completion Date

June 29, 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

5. Study Description

Brief Summary

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.

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

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dominant hand

Arm Type

Experimental

Arm 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

Arm Title

Non-dominant hand

Arm Type

Experimental

Arm 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

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 electrodes.

Primary Outcome Measure Information:

Title

Subjective Evaluation to Neurostimulation

Description

The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.

Time Frame

up to 1 hour postoperatively

Secondary Outcome Measure Information:

Title

Incidence of Residual Neuromuscular Blockade

Description

Number of subjects with train of four ratio < 0.9 after administration of reversal agent.

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 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

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

Learn more about this trial

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

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