Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Device: Train of four measurement

• Registration Number: NCT05120999
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. The comparison will be made by using electromyographic (EMG), such as TetraGraph, and acceloromyographic (AMG), such as TOFScan, monitors at the time of insertion of breathing tube.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-25
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-16
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients willing to participate and provide an informed consent.
• Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

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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 into the sterile field.
• Patients receiving a rapid sequence induction.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dominant hand	Train of four measurement	Application of either TetraGraph or TOFScan device on dominant hand
Non-Dominant hand	Train of four measurement	Application of either TetraGraph or TOFScan device on non-dominant hand

Primary Outcome Measures

Name	Time	Method
Time difference	During the initiation of anesthesia period	Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset

Secondary Outcome Measures

Name	Time	Method
Intubating conditions	During the initiation of anesthesia period	Assess intubating conditions once a complete neuromuscular blockade has been achieved either by TetraGraph or TOFScan measurements

Trial Locations

Locations (1)

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