Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring

NCT05120999 | Completed

• 1 other identifier: 21-007425
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade

Keywords

neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Time difference

  Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset

  During the initiation of anesthesia period

Secondary Outcomes (1)

• Intubating conditions

  During the initiation of anesthesia period

Study Arms (2)

Dominant hand

Application of either TetraGraph or TOFScan device on dominant hand

Device: Train of four measurement

Non-Dominant hand

Application of either TetraGraph or TOFScan device on non-dominant hand

Device: Train of four measurement

Interventions

Train of four measurement DEVICE

Use of either TetraGraph or TOFScan to measure the neuromuscular blockade

Dominant hand; Non-Dominant hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Qualified participants will be invited to participate in this study regardless of gender, sex, race, or religion.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Chaves-Cardona HE, Fouda EA, Hernandez-Torres V, Torp KD, Logvinov II, Heckman MG, Renew JR. Comparison of onset of neuromuscular blockade with electromyographic and acceleromyographic monitoring: a prospective clinical trial. Braz J Anesthesiol. 2023 Jul-Aug;73(4):393-400. doi: 10.1016/j.bjane.2023.04.004. Epub 2023 May 1.

  PMID: 37137388 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• J. Ross Renew, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 16, 2021
• Study Start: October 25, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

US (1)