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NCT03891381 · ClinicalTrials.gov registry record · NA
Electromyographic Monitoring and Postoperative Recovery
A NA study, sponsored by Endeavor Health.
- Terminated
- Registry status
- NA
- Development phase
- 130
- Enrollment target
NCT03891381: Clinical Trial NA study, sponsored by Endeavor Health.
NCT03891381 is a NA study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891381, a NA study, was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 130 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 residual 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 safely removed. At the present time, there is only one commercially available quantitative monitor produced in the United States -the TOF-Watch. The TOF-Watch 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 TetraGraph, an electromyography (EMG) device) in the clinical setting. Patients will be randomized to receive either electromyography monitoring (EMG group-using the TetraGraph) or qualitative peripheral nerve stimulator monitoring (PNS group-the standard type of neuromuscular monitoring used at NorthShore University HealthSystem). The primary endpoint of the investigation is the incidence of postoperative residual blockade (defined as a TOF ratio \< 0.9 with TOF-Watch, the current "gold standard quantitative monitor). Secondary endpoints include a variety of standard clinical recovery variables.
Primary Outcome
the percentage of patients admitted to the postanesthesia care unit with train-of-four ratios \< 0.9 will be determined
Interventions
- DEVICE Tetragraph quantitative monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2020-10-20 |
| Phase | NA |
Why NCT03891381 stopped before completion
NCT03891381 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Tetragraph quantitative monitoring is the first listed.
NCT03891381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03891381 about?
NCT03891381 is a clinical study titled "Electromyographic Monitoring and Postoperative Recovery". 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 residual neuromuscular blockade is through the use of quantitative neuromuscular monitors. These de...
What is the current status of trial NCT03891381?
This trial is currently terminated. It is a NA study. The enrollment target is 130 participants. The study started on 2019-03-26. Estimated completion is 2020-10-20.
What interventions are being tested in trial NCT03891381?
The interventions under investigation include: Tetragraph quantitative monitoring (DEVICE).
Who is sponsoring clinical trial NCT03891381?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03891381's enrollment target sits among peer trials
130 733rd of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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