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NCT05716282
Estimation of Neuromuscular Recovery - a Validation Study
Conditions: Neuromuscular Blockade Monitoring
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Erasme University Hospital
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%.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsPatients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuroniumExclusion Criteria:patient refusal to participateknown or suspected allergy to rocuroniumBody mass index < 20 kg/m2Body mass index > 30 kg/m2hepatic insufficiency, either clinical or hepatic test abnormalitiesrenal insufficiency defined as a clearance < 40 mL/min (calculated by the Modification of diet in renal disease (MDRD) formula
Source: ClinicalTrials.gov (NCT05716282). StuddyBuddy aggregates publicly available trial information.