Estimation of Neuromuscular Recovery - a Validation Study
- Conditions
- Neuromuscular Blockade Monitoring
- Interventions
- Other: Accuracy of neuromuscular recovery estimation
- Registration Number
- NCT05716282
- Lead Sponsor
- Erasme University Hospital
- 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age ≥ 18 years
- Patients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuronium
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NMB estimation group Accuracy of neuromuscular recovery estimation 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CUB Hôpital Erasme
🇧🇪Brussels, Belgium