Neuromuscular Blockade Monitoring Clinical Trial
Official title:
Estimation of Neuromuscular Transmission Recovery After Rocuronium Induced Block - Validation Study of a New Algorithm
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%.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | CUB Hôpital Erasme | Brussels |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03146767 -
The Staircase Phenomenon Implications on Neuromuscular Block Monitoring
|
N/A | |
Not yet recruiting |
NCT05228223 -
Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block
|
N/A |