Estimation of Neuromuscular Recovery - a Validation Study

Study Overview
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Brief Summary
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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%.

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

Conditions
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Neuromuscular Blockade Monitoring

Intervention / Treatment
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* Other: Accuracy of neuromuscular recovery estimation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NMB estimation group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular Blocking Agents, Neuromuscular Monitoring, Neuromuscular Nondepolarizing Agents