Clinical trial NCT03117387: Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission
Official title: Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission Monitoring During Recovery of Moderate and Deep Neuromuscular Block Compared to Acceleromyography and Electromyography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-04-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: American society of Anesthesiologist Physical Status class I-III patients \>18 years of age BMI either \< 30 or \> 30 kg/m2

Brief summary: Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block during anesthesia. However AMG is known to be inaccurate when compared to the gold standard in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the patients arms require to be positioned next to the body and beneath surgical drapes, AMG measurements are often hindered and inaccurate. The TOF cuff is a new device which measures neuromuscular blockade at the upper arm with a blood pressure cuff. It overcomes the previously mentioned disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been investigated.

This study aims to compare the bias, limits of agreement and precision of the Train-of-Four cuff relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients with normal body mass index and morbidly obese patients.


Eligibility criteria: Inclusion Criteria:

* American society of Anesthesiologist Physical Status class I-III
* \>18 years of age
* Ability to give oral and written informed consent

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Women who are or may be pregnant or are currently breast feeding;
* Renal insufficiency, as defined by a glomerular filtration rate \< 30 ml/min
* Scheduled for anesthesia without the use of muscle relaxants.

Primary outcomes:
measure: Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count)
timeFrame: at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below
Secondary outcomes:
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
state: Zuid Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Albert Dahan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: