Last reviewed · How we verify
NCT05716282
Estimation of Neuromuscular Recovery - a Validation Study
trial testing Accuracy of neuromuscular recovery estimation in Neuromuscular Blockade Monitoring in 100 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Erasme University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 2 March 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 March 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Accuracy of neuromuscular recovery estimation
Conditions studied
- Neuromuscular Blockade Monitoring — all drugs for Neuromuscular Blockade Monitoring →
Sponsor
Erasme University Hospital
Who can join
18 and older, any sex, with Neuromuscular Blockade Monitoring. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neuromuscular blocking (NMB) agents are used in the vast majority of surgical interventions. Although pharmacokinetic and pharmacodynamic data are available, there is a large interindividual variability in the time needed for recovery after neuromuscular blocking agents. In a previous study (NTC03550664) a mathematical model in order to estimate for each patient the time needed for full recovery based on the first measurable elements of train-of-four (TOF) recovery was established. After the first 14 TOF measurements, the estimated time to reach a recovery of 90%, expressed as % of recovery per 10 min, is calculated. In this study, this algorithm will be evaluated on a new cohort of patients in order to measure its accuracy and precision. Patients scheduled for surgery with a single dose of 0.6 mg/kg of rocuronium will be included in this prospective observational study. Neuromuscular transmission will be measured at the adductor pollicis using the TOFScan (IdMed, Marseille, France), a CE approved, commercially available monitor for neuromuscular transmission. TOF ratios will be measured every 30 s and recorded on a PC connected to the TOFScan. According to our algorithm, patients will be classified as slow, intermediate or fast recovery; speed of recovery will be measured as % of recovery per 10 min. A McNemar test will be used to assess the correct classification of patients in each group. Accuracy of the estimated speed of recovery will be assessed by comparing to the 95% confidence interval of our model. If real speed of recovery falls within the 95% confidence interval of the model, the model will be classified as accurate. These measurements will be done at 2 time points: - first estimation available and - after TOF ratio has recovered to 40%.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05716282
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Erasme University Hospital trials
Trials by the same sponsor.
- NCT07532733 — Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure · NA · not yet recruiting
- NCT07532681 — Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Su · NA · not yet recruiting
- NCT07457879 — Impact of the Reimbursement of Fibrinogen in Cardiac Surgery · not yet recruiting
- NCT07184593 — Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients · not yet recruiting
- NCT07369232 — Cerebral Hemodynamic Effects of Oxygen and Antioxidants (CHEOXANT) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05716282 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erasme University Hospital
- Last refreshed: 19 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05716282.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing