Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring

Neuromuscular Blockade Clinical Trial

Official title:

Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring: A Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120999
• Other study ID #: 21-007425
• Status: Completed
• Start date: October 25, 2021
• Est. completion date: January 14, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• Train of four measurement
Use of either TetraGraph or TOFScan to measure the neuromuscular blockade

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	Time difference	Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset	During the initiation of anesthesia period
Secondary	Intubating conditions	Assess intubating conditions once a complete neuromuscular blockade has been achieved either by TetraGraph or TOFScan measurements	During the initiation of anesthesia period

External Links

•   Mayo Clinic Clinical Trials