Acceleromyographic Assessment of Neuromuscular Blockade: TOF-Watch-SX Versus TOFscan
Status unconfirmed · Phase 4
Conditions studied: Neuromuscular Blockade
In brief
Muscle relaxants are administered to most patients undergoing general anesthesia in order to facilitate the placement of an endotracheal tube and improve operating conditions. Despite routine reversal of these agents, many patients arrive in the recovery room with evidence of residual muscle weakness. Many studies have demonstrated that residual neuromuscular blockade (weakness) is a common occurrence after surgery. The only method of reliably detecting the presence of perioperative 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 stand-alone quantitative monitor available in the United States -the TOF-Watch (an acceleromyography device). 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 TOFscan (a new three dimensional acceleromyography device). In order to study the accuracy of this new device, the TOFscan will be compared to the current "clinical gold standard", the TOF-Watch-SX.
Key facts
- Study ID
- NCT02433769
- Run by
- Endeavor Health
- People needed
- 30
- Starts
- 2015-04-01
- Expected to finish
- 2017-05-01
- Last updated by the study team
- 2017-04-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ASA I to III patients requiring neuromuscular blockade in the operating room
You may not qualify if…
- presence of an underlying neuromuscular disease
- use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate)
- presence of renal or hepatic disease
- procedures preventing access to both of the upper extremities.
Where it is running
- NorthShore University HealthSystem — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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