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NCT01678625 · ClinicalTrials.gov registry record
Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade
A clinical trial, sponsored by Endeavor Health.
- Terminated
- Registry status
- 30
- Enrollment target
NCT01678625: Clinical Trial study, sponsored by Endeavor Health.
NCT01678625 is a clinical trial that was terminated before completion, run by Endeavor Health. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01678625 was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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.)
Interventions
- DEVICE Train-of-four ratio calculation (T4-EMG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-12 |
Why NCT01678625 stopped before completion
NCT01678625 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Train-of-four ratio calculation (T4-EMG) is the first listed.
NCT01678625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01678625 about?
NCT01678625 is a clinical study titled "Electromyographic Assessment of Onset and Recovery of Neuromuscular Blockade". 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. T...
What is the current status of trial NCT01678625?
This trial is currently terminated. The enrollment target is 30 participants. The study started on 2012-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01678625?
The interventions under investigation include: Train-of-four ratio calculation (T4-EMG) (DEVICE).
Who is sponsoring clinical trial NCT01678625?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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