Estimation of Neuromuscular Recovery - a Validation Study

NCT05716282 | Recruiting

• 1 other identifier: NMB rec_estimation valid
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Neuromuscular Blocking Agents; Neuromuscular Monitoring; Neuromuscular Nondepolarizing Agents

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

NMB estimation group

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

Interventions

Accuracy of neuromuscular recovery estimation OTHER

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

NMB estimation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for surgery with a single bolus administartion of 0.6 mg/kg of rocuronium

You may qualify if:

• Age ≥ 18 years
• Patients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuronium

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

CUB Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

Related Publications (3)

• 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.

  PMID: 19222435 BACKGROUND

• 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.

  PMID: 17635389 BACKGROUND

• 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.

  PMID: 29365307 BACKGROUND

Central Study Contacts

Denis Schmartz, MD

CONTACT

+3225553919; denis.schmartz@hubruxelles.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 8, 2023
• Study Start: March 2, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)