Thumb vs Great Toe Recovery

NCT04312256 | Completed Results FDA Device

• 1 other identifier: 19-011705
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Residual Neuromuscular Blockade

Keywords

Neuromuscular Blockade; Tetragraph; AMG; EMG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  Up to 1 hour postoperatively

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

  Up to 1 hour postoperatively

Study Arms (1)

Dominant Hand and great toe

EXPERIMENTAL

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

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 (ECG) electrodes.

Dominant Hand and great toe

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 non-depolarizing NMBA agents administered intraoperatively.
• Patients with planned administration of sugammadex as a neuromuscular blocking reversal agent.

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: August 18, 2020
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: June 4, 2024
• Results First Posted: December 14, 2021

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)