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Studies

Observational Recruiting

NCT05716282 on ClinicalTrials.gov

Estimation of Neuromuscular Recovery - a Validation Study

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

  • Sponsor: Erasmus Hospital
  • Enrollment: 100 (Estimated)
  • Study start: 2023-03-02 (Actual)
  • Primary completion: 2024-12-31 (Estimated)
  • Study completion: 2025-03-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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%.

Conditions

  • Neuromuscular Blockade Monitoring

Intervention / Treatment

  • Other: Accuracy of neuromuscular recovery estimation

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

Countries

Belgium

Locations and Investigators