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Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
T4 Analytics
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01678625
First received: August 28, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting the presence of neuromuscular blockade is through the use of quantitative neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the endotracheal tube can be removed. At the present time, there is only one commercially-available quantitative monitor available in the United States -the TOF-Watch. It is not used by many clinicians because it requires experience to obtain accurate results, is expensive, and is subject to interference by factors in the operating room. The aim of this investigation is to examine a new quantitative monitor (the T4-EMG (EMG = electromyography) that may not be subject to the same limitations as the TOF-Watch AMG (AMG = acceleromyography). In order to study the accuracy of this new device, the T4-EMG will be compared to the current "clinical gold standard", the TOF-Watch.


Condition Intervention
Residual Neuromuscular Blockade
Device: Train-of-four ratio calculation (T4-EMG)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade

Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Train-of-four (TOF)ratio [ Time Frame: TOF ratios will be measured for the duration of the operation, approximately 3 hours ] [ Designated as safety issue: Yes ]
    Train-of-four ratios during recovery of neuromuscular blockade will be compared between the AMG and EMG devices (at a TOF ratio of 0.6, 0.7, 0.8, and 0.9.)


Estimated Enrollment: 44
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acceleromyography group
Train-of-four ratio calculation (TOF-Watch)
Device: Train-of-four ratio calculation (T4-EMG)
TOF ratios will be compared between the EMG and AMG groups
Electromyography group
Train-of-four ratio calculation (T4-EMG)
Device: Train-of-four ratio calculation (T4-EMG)
TOF ratios will be compared between the EMG and AMG groups

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting for elective surgical procedures under general anesthesia with an expected duration greater than 60 minutes will be enrolled in this study.

Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists Status I to III patients requiring neuromuscular blockade in the operating room will be eligible for enrollment

Exclusion Criteria:

  • 1) presence of an underlying neuromuscular disease; 2) use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate); 3) presence of renal or hepatic disease; or 4) procedures preventing access to at least one of the upper extremities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678625

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
T4 Analytics
Investigators
Principal Investigator: Glenn S. Murphy, MD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: Glenn S. Murphy, MD, Director, Clinical Research, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01678625     History of Changes
Other Study ID Numbers: EH12-158
Study First Received: August 28, 2012
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
Residual neuromuscular blockade
Train-of-four
Acceleromyography
Electromyography

ClinicalTrials.gov processed this record on November 20, 2014