Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting

Residual Neuromuscular Blockade Clinical Trial

Official title:

Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352140
• Other study ID #: 20-000629
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: February 14, 2022

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• 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 laparoscopic or robotic 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

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 electrodes.
• ToFscan
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured

Locations

Country	Name	City	State
France	Université de Lorraine, CHU de Brabois	Vandœuvre-lès-Nancy
Hungary	University of Debrecen	Debrecen
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  France,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Values Between Tetragraph and ToFscan	The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan	Up to 1 hour postoperatively
Secondary	Incidence of Residual Neuromuscular Blockade	Number of patients with train of four ratio < 0.9 after administration of reversal agent.	Up to 1 hour postoperatively

External Links

•   Mayo Clinic Clinical Trials