Neuromuscular Blockade Monitoring
Conditions
Keywords
Neuromuscular Blocking Agents, Neuromuscular Monitoring, Neuromuscular Nondepolarizing Agents
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%.
Interventions
OTHERAccuracy 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
Sponsors
Erasme University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactDenis Schmartz, MD
Outcome results
None listed