Thumb vs Great Toe Recovery

Not Applicable

Completed

• Conditions: Residual Neuromuscular Blockade
• Interventions: Device: TetraGraph

• Registration Number: NCT04312256
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Study Start: 2020-08-18
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Results First Submitted: 2021-11-15
• Results First Submitted QC: 2021-11-15
• Results First Posted: 2021-12-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles	Up to 1 hour postoperatively	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	Up to 1 hour postoperatively	The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds.

Secondary Outcome Measures

Name	Time	Method
Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles	Up to 1 hour postoperatively	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	Up to 1 hour postoperatively	The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States