Predictive Modelling of the Intraoperative Train-of-Four... | NCT04518761

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

NCT04518761

Sponsor

Universitair Ziekenhuis Brussel

Status

Recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

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

Interventions

Elective surgery

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Aug 14, 2020

First Submission Date that Met QC Criteria

Aug 14, 2020

First Posted Date

Aug 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

Apr 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective group			Procedure: Elective surgery
Retrospective group			Procedure: Elective surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elective surgery	Procedure	Any patient who needs to undergo an elective surgery.	Prospective group Retrospective group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TOF-ratio	Train of four percentage	1 day

Secondary Outcomes

Measure	Description	Time Frame
TOF-count	Train of four count	1 day

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel	Recruiting	Jette	Brussels Capital	1090	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38573367	Derived	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.
37542918	Derived	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.