NCT06230653

Mechanomyography Reloaded? A Randomized Prospective Agreement Study

A Single-centre, Randomised, Prospective Agreement Study to Determine the Clinical Performance and Safety of a Best Practice Medical Device With a Novel Sensor

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Neuromuscular Blockade

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2024-01-30
• Last updated: 2024-01-30