An observational study in Neuromuscular Blockade, sponsored by University Hospital Ulm. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by University Hospital Ulm · Observational
Neuromuscular monitoring is used to evaluate neuromuscular function intraoperatively and to ensure complete neuromuscular recovery at the end of anaesthesia. Therefore, the lack of reliable neuromuscular monitoring devices that are not cumbersome to use is a major shortcoming for anaesthesia. A recently developed mechanomyography (MMG) device may meet these partially unmet needs due to its measurement of the patient's contractile force instead of its surrogates (i.e., acceleration, velocity), including the response to physiologically relevant tetanic stimulation. However, it is unclear whether the reliability of the newly developed MMG device is similar to or better than the currently available gold standard of neuromuscular monitoring based on electromyography (EMG).
The MEMORY trial is a randomized clinical agreement study which will prospectively enrol thirty ASA 1 or 2 patients ≥ 18 years scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions. The patient's neuromuscular function is measured on one hand with MMG and the other hand with EMG in a randomised fashion. Additionally, randomisation will be stratified the domination of one hand.
In the MEMORY trial we will test the hypothesis, that a newly developed MMG sensor provides not less reliable measurements of neuromuscular function compared to EMG in adult patients. Reliability includes agreement, precision, and the absence of staircase phenomenon and idiosyncratic responses to train-of-four (TOF) stimulation. In addition, we will explore if measurement of tetanic fade will provide more precise information about complete neuromuscular recovery than the current standard of TOF ratio >0.9.
University Hospital Ulm is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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The MEMORY trial is a randomized clinical agreement study which will prospectively enrol adult ASA 1 or 2 patients scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.
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Exclusion Criteria:
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mechanomyography-device will be examined on the dominant arm.
Mechanomyography-device will be examined on the non-dominant arm.
Precision of the Mechanomyography
Measured by the repeatability coefficient at baseline and at complete neuromuscular recovery
Time frame: intraoperative
Agreement of the TOF ratio between Electromyography and Mechanomyography
Agreement of the TOF ratio at 7 predefined TOF ratios: 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, and 0.9
Time frame: intraoperative
Confirmation of handling and precision of Mechanomyography sensor
Investigation of baseline stability (i.e., no staircase phenomenon of the first twitch response and the TOF ratio), occurrence and magnitude of idiosyncratic TOF ratio \> 1.0 during baseline measurement, repeatability of the TOF ratio during recovery from a rocuronium induced neuromuscular blockade, and sensitivity of the TOF ratio to changing the hand position during baseline measurements.
Time frame: intraoperative
Tetanic fade
Measurement of the tetanic fading at baseline, at a TOF ratio of 0.9 measured by EMG, at a TOF ratio of 0.95 measured by EMG, and 5 min after a bolus of 2 mg/kg sugammadex
Time frame: intraoperative
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This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University Hospital Ulm