Thumb vs Great Toe Recovery

Residual Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312256
• Other study ID #: 19-011705
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: January 19, 2021

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Residual Neuromuscular Blockade

Intervention

Device:
• TetraGraph
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 1 hour postoperatively
Secondary	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.	Up to 1 hour postoperatively

External Links

•   Mayo Clinic Clinical Trials