Clinical trial NCT05716282: Estimation of Neuromuscular Recovery - a Validation Study
Official title: Estimation of Neuromuscular Transmission Recovery After Rocuronium Induced Block - Validation Study of a New Algorithm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Blockade Monitoring
Keywords: Neuromuscular Blocking Agents
Neuromuscular Monitoring
Neuromuscular Nondepolarizing Agents
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for surgery with a single bolus administartion of 0.6 mg/kg of rocuronium

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of NMB speed of recovery estimation
timeFrame: 6 hours
measure: Precision of NMB speed of recovery estimation
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme
Study officials:
References:
citation: Fuchs-Buder T, Schreiber JU, Meistelman C. Monitoring neuromuscular block: an update. Anaesthesia. 2009 Mar;64 Suppl 1:82-9. doi: 10.1111/j.1365-2044.2008.05874.x.
citation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
citation: Ortega R, Brull SJ, Prielipp R, Gutierrez A, De La Cruz R, Conley CM. Monitoring Neuromuscular Function. N Engl J Med. 2018 Jan 25;378(4):e6. doi: 10.1056/NEJMvcm1603741. No abstract available.