Estimation of Neuromuscular Recovery - a Validation Study

Neuromuscular Blockade Monitoring Clinical Trial

Official title:

Estimation of Neuromuscular Transmission Recovery After Rocuronium Induced Block - Validation Study of a New Algorithm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716282
• Other study ID #: NMB rec_estimation valid
• Status: Recruiting
• Start date: March 2, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Erasme University Hospital
• Contact: Denis Schmartz, MD
• Phone: +3225553919
• Email: denis.schmartz[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Patients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuronium

Exclusion Criteria:

• patient refusal to participate
• known or suspected allergy to rocuronium
• Body mass index < 20 kg/m2
• Body mass index > 30 kg/m2
• hepatic insufficiency, either clinical or hepatic test abnormalities
• renal insufficiency defined as a clearance < 40 mL/min (calculated by the Modification of diet in renal disease (MDRD) formula

Related Conditions & MeSH terms

• Neuromuscular Blockade Monitoring

Intervention

Other:
• Accuracy of neuromuscular recovery estimation
Accuracy of the estimation of neuromuscular recovery will be measured as: Correct attribution of the patients to the groups slow, intermediate or fast recovery Real speed of recovery falls between 95 confidence interval of the estimated speed of recovery

Locations

Country	Name	City	State
Belgium	CUB Hôpital Erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x. — View Citation

Fuchs-Buder T, Schreiber JU, Meistelman C. Monitoring neuromuscular block: an update. Anaesthesia. 2009 Mar;64 Suppl 1:82-9. doi: 10.1111/j.1365-2044.2008.05874.x. — View Citation

Ortega R, Brull SJ, Prielipp R, Gutierrez A, De La Cruz R, Conley CM. Monitoring Neuromuscular Function. N Engl J Med. 2018 Jan 25;378(4):e6. doi: 10.1056/NEJMvcm1603741. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of NMB speed of recovery estimation	A McNemar test will be used to test the attribution of each patient to one of the groups (slow, intermediate or fast recovery)	6 hours
Primary	Precision of NMB speed of recovery estimation	Speed of recovery estimation (% per 10 min) will be considered precise if it falls within the 95% confidence interval boundaries of the model	6 hours