NCT04518761

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2020Dec 2026

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

August 14, 2020

Last Update Submit

April 28, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • TOF-ratio

    Train of four percentage

    1 day

Secondary Outcomes (1)

  • TOF-count

    1 day

Study Arms (2)

Prospective group

Procedure: Elective surgery

Retrospective group

Procedure: Elective surgery

Interventions

Elective surgeryPROCEDURE

Any patient who needs to undergo an elective surgery.

Prospective groupRetrospective group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

AZ Sint Jan

Bruges, WV, 8000, Belgium

NOT YET RECRUITING

Related Publications (2)

  • 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: 38573367DERIVED

  • 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: 37542918DERIVED

MeSH Terms

Interventions

Elective Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 19, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

BE(2)