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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518761
• Other study ID #: TOFPROS02
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Elective surgery
Any patient who needs to undergo an elective surgery.

Locations

Country	Name	City	State
Belgium	AZ Sint Jan	Brugge	WV
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOF-ratio	Train of four percentage	1 day
Secondary	TOF-count	Train of four count	1 day