Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Neuromuscular Blockade

Treatments: Diagnostic Test: Measurements of the level of neuromuscular blockade

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03117387

P17.050

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 4 patient groups

moderate neuromuscular block, normal body mass index

Description:

Patients with normal BMI (\< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches)

Treatment:

Diagnostic Test: Measurements of the level of neuromuscular blockade

deep neuromuscular block, normal body mass index

Description:

Patients with normal BMI (\< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches)

Treatment:

Diagnostic Test: Measurements of the level of neuromuscular blockade

moderate neuromuscular block, high body mass index

Description:

Patients with high BMI (\> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches)

Treatment:

Diagnostic Test: Measurements of the level of neuromuscular blockade

deep neuromuscular block, high body mass index

Description:

Patients with high BMI (\> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches)

Treatment:

Diagnostic Test: Measurements of the level of neuromuscular blockade