Reversing muscle relaxation during general anesthesia
Reversal of Neuromuscular Blockade During the General Anaesthesia
NA · Tampere University Hospital · NCT04048655
This study is testing if some patients experience unexpected muscle relaxation after their anesthesia is reversed during surgery to see how common it is.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tampere University Hospital (other) |
| Locations | 1 site (Tampere) |
| Trial ID | NCT04048655 on ClinicalTrials.gov |
What this trial studies
This study investigates the phenomenon of spontaneous muscle relaxation occurring after the reversal of neuromuscular blockade with neostigmine in patients undergoing elective surgery. It aims to monitor the recovery of neuromuscular function induced by rocuronium using train of four stimulations and electromyography. After administering the reversal agent, the study will observe patients for an additional 30 minutes to determine if the train of four ratio falls below the safe level of 90%. The goal is to calculate the incidence of this post-recovery relaxation phenomenon.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective surgeries requiring general anesthesia with a body mass index less than 35 kg/m².
Not a fit: Patients with central nervous system diseases, trauma, or conditions affecting the peripheral nervous system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of neuromuscular blockade reversal during surgeries.
How similar studies have performed: While there have been individual reports on this phenomenon, this study represents a novel approach to systematically assess its incidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective surgery requiring general anaesthesia * Surgery is assumed to last more than 45 minutes * Body mass index less than 35kg/ m² Exclusion Criteria: * Disease of central nervous system * Trauma of central nervous system * Disease affecting peripheral nervous system * Medication affecting peripheral nervous system
Where this trial is running
Tampere
- Tampere University Hospital — Tampere, Finland (RECRUITING)
Study contacts
- Principal investigator: Jarno Salminen, Licenciate — Tampere University Hospital
- Study coordinator: Jarno Salminen, Licenciate
- Email: jarno.salminen@fimnet.fi
- Phone: +358503480709
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.
Conditions: Neuromuscular Blockade, neuromuscular blockade, neostigmine, muscle relaxation, train of four, rocuronium