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

Universitair Ziekenhuis Brussel

Status: Enrolling

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

Treatments: Procedure: Elective surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04518761

TOFPROS02

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Prospective group

Treatment:

Procedure: Elective surgery

Retrospective group

Treatment:

Procedure: Elective surgery