Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio

NCT ID: NCT04518761

Last Updated: 2024-05-20

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Analyse Neuromuscular Monitoring for Developing a Model to Predict TOF Ratio During Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective group

Elective surgery

Intervention Type PROCEDURE

Any patient who needs to undergo an elective surgery.

Retrospective group

Elective surgery

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

AZ Sint Jan

Bruges, WV, Belgium

Site Status NOT_YET_RECRUITING

Countries

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Belgium

Facility Contacts

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Evelien Vandeurzen, Biomedical Sciences

Role: primary

024749237

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.

Reference Type DERIVED
PMID: 38573367 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37542918 (View on PubMed)

Other Identifiers

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TOFPROS02

Identifier Type: -

Identifier Source: org_study_id

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