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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Elective surgery

    Procedure/Surgery

    Any patient who needs to undergo an elective surgery.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Prospective group1 intervention
Group B: Retrospective group1 intervention

Trial outcomes

Primary outcomes

1

TOF-ratio

Train of four percentage

Time frame
1 day

Secondary outcomes

1

TOF-count

Train of four count

Time frame
1 day

Other outcomes

Sponsors and contacts

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