Evaluation of the TOF CUFF for Perioperative Neuromuscular Transmission

Study Overview
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Brief Summary
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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 NMB 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 TOF 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.

Official Title
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Evaluation of the TOF CUFF for Perioperative Neuromuscular Transmission Monitoring During Recovery of Moderate and Deep Neuromuscular Block Compared to Acceleromyography and Electromyography

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| moderate neuromuscular block, normal body mass index<br>Patients with normal BMI (< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) | Other: no intervention<br>* This study contains no interventions<br>|
| deep neuromuscular block, normal body mass index<br>Patients with normal BMI (< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) | Other: no intervention<br>* This study contains no interventions<br>|
| moderate neuromuscular block, high body mass index<br>Patients with high BMI (> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) | Other: no intervention<br>* This study contains no interventions<br>|
| deep neuromuscular block, high body mass index<br>Patients with high BMI (> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) | Other: no intervention<br>* This study contains no interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of neuromuscular block as measured by a train of four ratio or post tetanic count will be compared between the three devices by bland altman analysis | During anesthesia, depth of neuromuscular block will be assessed at regular intervals | intraoperative |