Estimation of Neuromuscular Recovery - a Validation Study
Study Details
Study Description
Brief 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%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| NMB estimation group All patients undergoing surgery with a single dose of 0.6 mg/kg rocuronium and quantitative neuromuscular transmission monitoring by TOFScan at the adductor pollicis. |
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
|
Outcome Measures
Primary Outcome Measures
- Accuracy of NMB speed of recovery estimation [6 hours]
A McNemar test will be used to test the attribution of each patient to one of the groups (slow, intermediate or fast recovery)
- Precision of NMB speed of recovery estimation [6 hours]
Speed of recovery estimation (% per 10 min) will be considered precise if it falls within the 95% confidence interval boundaries of the model
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Patients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuronium
Exclusion Criteria:
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patient refusal to participate
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known or suspected allergy to rocuronium
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Body mass index < 20 kg/m2
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Body mass index > 30 kg/m2
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hepatic insufficiency, either clinical or hepatic test abnormalities
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renal insufficiency defined as a clearance < 40 mL/min (calculated by the Modification of diet in renal disease (MDRD) formula
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Erasme University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- NMB rec_estimation valid