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

NCT04352127 | Completed Results FDA Device

• 1 other identifier: 20-000619
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Residual Neuromuscular Blockade

Keywords

Neuromuscular Blockade; Tetragraph; AMG; EMG

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 1 hour postoperatively

Secondary Outcomes (1)

• Incidence of Residual Neuromuscular Blockade

  Up to 1 hour postoperatively

Study Arms (2)

Dominant hand

EXPERIMENTAL

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

Device: TetraGraph

Non-dominant hand

EXPERIMENTAL

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

Device: TetraGraph

Interventions

TetraGraph DEVICE

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.

Dominant hand; Non-dominant hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: J. Ross Renew, M.D.
• Organization: Mayo Clinic

Renew.J@mayo.edu

904-956-3328

Study Officials

• J.Ross Renew, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: August 18, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: November 10, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)