Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elective surgery.
- Who it may be relevant to
- Registry conditions: Analyse Neuromuscular Monitoring for Developing a Model to Predict TOF Ratio During Anesthesia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Neuromuscular Blocking Agents (NMBAs) are routinely administered to patients in a multiplicity o anaesthetic settings in order to paralyze and impede (re)active muscular contraction. The availability of monitoring devices allowing an accurate measurement fo the degree of neuromuscular block during anesthesia has raised the standards for a proper evidence-based use of NMBAs. 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.
Interventions
- Procedure Elective surgery
Any patient who needs to undergo an elective surgery.
Primary outcome measures
- TOF-ratio [Time frame: 1 day]
Secondary outcome measures (1)
- TOF-count [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.
- Administration of General Anesthesia by means of Total Intravenous Anesthesia technique.
- Use of Rocuronium as a neuromuscular blocking agent.
Exclusion criteria
- Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure
- Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 2 centers
- UZ Brussel — Jette
- AZ Sint Jan — Bruges
Publications
- 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. PMID 38573367
- 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. PMID 37542918
Identifiers
NCT: NCT04518761 · TOFPROS02