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NCT Number: NCT04518761

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel, Jette, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elective Surgery

Procedure

Any patient who needs to undergo an elective surgery.

Primary outcomes

  1. TOF-ratio

    Time frame: 1 day

    Train of four percentage

Secondary outcomes

  1. TOF-count

    Time frame: 1 day

    Train of four count

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.