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Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade

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ClinicalTrials.gov Identifier: NCT01678625
Recruitment Status : Terminated (Company making the device no longer in existence. Did not finish supplying data to research team)
First Posted : September 5, 2012
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
T4 Analytics
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute

Brief Summary:
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 or disease Intervention/treatment
Residual Neuromuscular Blockade Device: Train-of-four ratio calculation (T4-EMG)

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade
Study Start Date : June 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Group/Cohort Intervention/treatment
Acceleromyography group
Train-of-four ratio calculation (TOF-Watch-SX-Bluestar enterprise)
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



Primary Outcome Measures :
  1. Train-of-four (TOF)ratio [ Time Frame: TOF ratios will be measured for the duration of the operation, approximately 3 hours ]
    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.)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2015

Keywords provided by Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute:
Residual neuromuscular blockade
Train-of-four
Acceleromyography
Electromyography

Additional relevant MeSH terms:
Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes