N/A
Completed N=250
Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission
Neuromuscular Blockade
Source: ClinicalTrials.gov NCT03117387 ↗
Enrolled (actual)
250
Serious AEs
4.0%
Results posted
Mar 2024
Primary outcomePrimary: 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) — 0.312; 0.384; 3.405; -0.17 bias
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
0.312; 0.384; 3.405; -0.17 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03117387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.