Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade
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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 |
- 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: | March 2013 |
| Estimated Primary Completion Date: | March 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 |
Patients presenting for elective surgical procedures under general anesthesia with an expected duration greater than 60 minutes will be enrolled in this study.
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| Contact: Glenn S. Murphy, MD | 847-570-2760 | dgmurphy2@yahoo.com |
| United States, Illinois | |
| NorthShore University HealthSystem | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: Glenn S Murphy, MD 847-570-2760 dgmurphy@yahoo.com | |
| Principal Investigator: Glenn S Murphy, MD | |
| 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: | January 15, 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 May 22, 2013