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

Not Applicable

Completed

• Conditions: Residual Neuromuscular Blockade

• Registration Number: NCT04352127
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Study Start: 2020-08-18
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Results First Submitted: 2022-04-12
• Results First Submitted QC: 2022-04-12
• Results First Posted: 2022-05-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective Evaluation to Neurostimulation	up to 1 hour postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Residual Neuromuscular Blockade	Up to 1 hour postoperatively	Number of subjects with train of four ratio \< 0.9 after administration of reversal agent.

Trial Locations

Locations (1)

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