Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring

August 7, 2023 updated by: J. Ross Renew, M.D., Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dominant hand
Application of either TetraGraph or TOFScan device on dominant hand
Device: Train of four measurement
Use of either TetraGraph or TOFScan to measure the neuromuscular blockade
Non-Dominant hand
Application of either TetraGraph or TOFScan device on non-dominant hand
Device: Train of four measurement
Use of either TetraGraph or TOFScan to measure the neuromuscular blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time difference
Time Frame: During the initiation of anesthesia period
Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset
During the initiation of anesthesia period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubating conditions
Time Frame: During the initiation of anesthesia period
Assess intubating conditions once a complete neuromuscular blockade has been achieved either by TetraGraph or TOFScan measurements
During the initiation of anesthesia period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: J. Ross Renew, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

January 14, 2022

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-007425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuromuscular Blockade

Clinical Trials on Train of four measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe