Mechanomyography Reloaded? A Randomized Prospective Agreement Study

NCT06230653 | Unknown

• 1 other identifier: MEMORY
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Neuromuscular Blockade

Keywords

Mechanomyography; Neuromuscular Blockade; Electromyography; Tetanic fading

Outcome Measures

Primary Outcomes (1)

• Precision of the Mechanomyography

  Measured by the repeatability coefficient at baseline and at complete neuromuscular recovery

  intraoperative

Secondary Outcomes (2)

• Agreement of the TOF ratio between Electromyography and Mechanomyography

  intraoperative

• Confirmation of handling and precision of Mechanomyography sensor

  intraoperative

Other Outcomes (1)

• Tetanic fade

  intraoperative

Study Arms (2)

MMG on dominant arm

Mechanomyography-device will be examined on the dominant arm.

MMG on non-dominant arm

Mechanomyography-device will be examined on the non-dominant arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• age ≥ 18 years
• ASA \< 3
• scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions
• positioning during surgery with intraoperative access to both arms

You may not qualify if:

• allergy to muscle relaxants and reversal agents
• neuromuscular disease
• procedure is scheduled outside the operating room
• need of endotracheal intubation prior to surgery
• need of rapid sequence induction
• pregnancy, breastfeeding or 30 days postpartum
• surgical procedure or examination findings which are a contraindication for a supraglottic airway device
• employee of the investigator or study site directly involved in this study or other studies under the direction of the investigator or study site
• family member of the investigator
• custodial accommodation
• alcohol or drug abuse
• patients with preceding injuries impairing muscle or nerve function of the arm
• Participation in other studies with investigational drugs or devices within 4 weeks prior to screening or missing agreement not to participate in any other study at the same time or within a period of one month after the MEMORY study

Sponsors & Collaborators

• University Hospital Ulm: lead

Related Publications (1)

• Scholze AS, Ulm B, Kretsch N, Jungwirth B, Blobner M, Scheffenbichler FT. A single-centre, randomised comparison of the performance and safety of a novel mechanomyography sensor with electromyography. Br J Anaesth. 2026 Jan 7:S0007-0912(25)00830-X. doi: 10.1016/j.bja.2025.10.067. Online ahead of print.

  PMID: 41506970 DERIVED

Study Officials

• Manfred Blobner, MD PhD

  Department of Anesthesiology and Intensive Care Medicine, Technical University of Munich, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Scholze

CONTACT

00498941408974; anna.scholze@tum.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: January 22, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01