PI left institution
Sponsor study identifier
interventional
130
1 country
1
Study Start
March 26, 2019
Actual (reported)Primary Completion
October 20, 2020
Actual (reported)Study Completion
October 20, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 20, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2019
Actual (reported)March 26, 2019
Actual (reported)March 27, 2019
Actual (reported)October 20, 2020
Actual (reported)October 20, 2020
Actual (reported)Incidence of postoperative residual neuromuscular blockade
the percentage of patients admitted to the postanesthesia care unit with train-of-four ratios \< 0.9 will be determined
15 minutes
Incidence of hypoxemic events in the postanesthesia care unit
60 minutes
Airway obstruction
60 minutes
Symptoms of muscle weakness
15 minutes after admission to the postanesthesia care unit
Patients will be randomized to receive quantitative monitoring in the operating room. Neuromuscular management will be guided by information provided by the monitor
The screen of the Tetragraph will be covered so that information is not provided to the clinician. The monitor will therefore function as a standard peripheral nerve monitor (clinicians will only observe the response to nerve stimulation)
Neuromuscular monitoring will be guided by information provided by the Tetragraph
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NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Glenn S Murphy, MD
Endeavor Health
130 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2019
First Posted
March 27, 2019
Study Start
March 26, 2019
Primary Completion
October 20, 2020
Actual (reported)Study Completion
October 20, 2020
Actual (reported)Last Updated
December 21, 2021
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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