Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio
NCT ID: NCT04518761
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-07-01
2026-12-31
Brief Summary
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For this purpose, one of the most widely used methods is the Train of Four (TOF): transcutaneous application of a series of 4 square-wave supra-maximal electrical stimuli over the course of a nerve of choice (most commonly the ulnar nerve). These are applied at a frequency of 2Hz, and each with a duration of 0.2ms. These stimuli elicit a motor response on the adductor pollicis muscle, which on its turn dictates the adduction of the thumb. The acceleration of this movement can be followed by means of an uni/multi-directional accelerometer attached to the thumb. The ratio of the acceleration of the 4th and 1st elicited contractions is called the TOF-Ratio - a clinically and scientifically established method of assessing neuromuscular block recovery. A value of 1 translates a full recovery of the muscular function of a patient. In modern Anesthesia, the bar for deeming a recovery as adequate has been set at a minimum of a TOF-ratio of \>0.9, with some authors advocating a ratio of 1 as the only acceptable and complications avoiding result.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Prospective group
Elective surgery
Any patient who needs to undergo an elective surgery.
Retrospective group
Elective surgery
Any patient who needs to undergo an elective surgery.
Interventions
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Elective surgery
Any patient who needs to undergo an elective surgery.
Eligibility Criteria
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Inclusion Criteria
* Administration of General Anesthesia by means of Total Intravenous Anesthesia technique.
* Use of Rocuronium as a neuromuscular blocking agent.
Exclusion Criteria
* Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.
18 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Locations
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UZ Brussel
Jette, Brussels Capital, Belgium
AZ Sint Jan
Bruges, WV, Belgium
Countries
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Facility Contacts
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Hugo Carvalho, MD, PhD
Role: primary
References
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Verdonck M, Carvalho H, Fuchs-Buder T, Brull SJ, Poelaert J. Machine learning based analysis and detection of trend outliers for electromyographic neuromuscular monitoring. J Clin Monit Comput. 2024 Oct;38(5):1163-1173. doi: 10.1007/s10877-024-01141-6. Epub 2024 Apr 4.
Carvalho H, Verdonck M, Eleveld DJ, Ramirez D, D'Haese J, Flamee P, Geerts L, Wylleman J, Cools W, Barbe K, Struys MMRF, Poelaert J. Neuromuscular end-point predictive capability of published rocuronium pharmacokinetic/pharmacodynamic models: An observational trial. J Clin Anesth. 2023 Nov;90:111225. doi: 10.1016/j.jclinane.2023.111225. Epub 2023 Aug 3.
Other Identifiers
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TOFPROS02
Identifier Type: -
Identifier Source: org_study_id
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