TOF3D mechanomyograph for monitoring neuromuscular block during anesthesia.
The TOF3D Mechanomyograph. Evaluation of a New Device for Assessment of the Neuromuscular Block.
This project will test whether the TOF3D mechanomyograph measures muscle relaxation more precisely than standard acceleromyography in people having surgery under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Klinikum Hersfeld-Rotenburg Academic / other |
| Locations | 1 site (Bad Hersfeld) |
| Trial ID | NCT07371377 on ClinicalTrials.gov |
What this trial studies
The trial compares a new mechanomyography device (TOF3D) with standard acceleromyography in patients receiving neuromuscular blocking drugs during general anesthesia. Part 1 directly compares mechanomyograph readings to acceleromyograph readings, while Part 2 compares two mechanomyography modes that use different stimulation patterns. Investigators will record the time course of the neuromuscular block intraoperatively. Patients with anticipated difficult airway, increased aspiration risk, pregnancy, or neuromuscular disorders are excluded.
Who should consider this trial
Good fit: Adults scheduled for surgery under general anesthesia who will receive neuromuscular blocking agents and who do not have pregnancy, known neuromuscular disorders, a difficult airway, or elevated aspiration risk.
Not a fit: People who are pregnant, have neuromuscular disorders, have a known or anticipated difficult airway, or are not receiving neuromuscular blockers would not be eligible and would not benefit directly from this device.
Why it matters
Potential benefit: If successful, the device could provide more precise monitoring of muscle relaxation and help reduce the risk of residual paralysis after anesthesia.
How similar studies have performed: Mechanomyography has primarily been used in experimental settings and some reports suggest greater precision than acceleromyography, but direct clinical comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients scheduled for surgery requiring general anesthesia with neuromuscular blocking agents Exclusion Criteria: * anticipated or known difficult airway * increased risk for aspiration * pregnancy * neuromuscular disorders
Where this trial is running
Bad Hersfeld
- Department of Anesthesia and Intensive Care Medicine — Bad Hersfeld, Germany (Recruiting)
Study contacts
- Study coordinator: Stefan Soltesz, Professor
- Email: stefan.soltesz@klinikum-hef.de
- Phone: 0049 6621 88 922775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.