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RecruitingNCT06238219NMBA_periopUpdated Apr 19, 2024

Management of Neuromuscular Blocking Agents and Their Antagonism

An observational study in Neuromuscular Blocking Agents and Neuromuscular Monitoring, sponsored by Erasme University Hospital. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Erasme University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
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Study summary

Neuromuscular blocking agents (NMBA) are commonly used in clinical practice during general anesthesia to facilitate induction, intubation and surgery. Some studies have shown that their use can be deleterious if not codified. Recent recommendations concerning their use and antagonization were published in 2023.

Research hypothesis:

Using a single-center, retrospective practice study, we aim to analyze whether the 2023 ASA and ESAIC recommendations are being implemented regarding the use of neuromuscular blocking agents.

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Conditions studied

  • Neuromuscular Blocking Agents
  • Neuromuscular Monitoring
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In context

Lead sponsor

Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing surgery with use of neuromuscular blocking agents at our institution from 2018 to 2023.

Inclusion criteria

  • All patients undergoing surgery with use of neuromuscular blocking agents at our institution

Exclusion criteria

Exclusion Criteria:

  • Incomplete electronic anesthesia record
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • NMBA cohort

    Patients undergoing surgery under general anesthesia with use of neuromuscular blocking agents

    Drug: Neuromuscular Blocking Agent

Interventions

  • DrugNeuromuscular Blocking Agent

    Administration of any neuromuscular blocking agent for surgery under general anesthesia

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What researchers measure

Primary outcomes

  1. Adherence to ASA and ESAIC guidelines for the use and monitoring of neuromuscular bocking agents (%)

    Train of four (TOF) ratio and TOF-count, as well as post-tetanic count (PTC) will be extracted from the electronic anesthesia record together with the type, dosage and timing of neuromuscular blocking agents. At intubation, antagonisation and extubation, the use of monitoring, the correct dose for antagonising agents (neostigmine or sugammadex) will be recorded. Concordance with current guidelines from ASA (American society of anaesthesiologists) and ESAIC (European society of anaesthesia and intensive care) will be analysed with a Chi-square test (observed versus expected). The % of adherence to the guidelines will be reported.

    Time frame: 10 hours

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Study locations

1 of 1 sites recruiting
  • Hôpital Universitaire de Bruxelles - Hôpital erasme
    Brussels, 1070, Belgium
    Recruiting
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References and documents

Publications

  • Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, Meistelman C, Hunter JM, Ulm K, Blobner M; POPULAR Contributors. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019 Feb;7(2):129-140. doi: 10.1016/S2213-2600(18)30294-7. Epub 2018 Sep 14. Erratum In: Lancet Respir Med. 2019 Feb;7(2):e9. doi: 10.1016/S2213-2600(18)30467-3. PubMed 30224322 ↗
  • Blobner M, Hunter JM, Meistelman C, Hoeft A, Hollmann MW, Kirmeier E, Lewald H, Ulm K. Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data. Br J Anaesth. 2020 Jan;124(1):63-72. doi: 10.1016/j.bja.2019.08.023. Epub 2019 Oct 10. PubMed 31607388 ↗
  • Fuchs-Buder T, Brull SJ. Is less really more? A critical appraisal of a POPULAR study reanalysis. Br J Anaesth. 2020 Jan;124(1):12-14. doi: 10.1016/j.bja.2019.09.038. Epub 2019 Nov 2. No abstract available. PubMed 31685216 ↗
  • Thilen SR, Weigel WA, Todd MM, Dutton RP, Lien CA, Grant SA, Szokol JW, Eriksson LI, Yaster M, Grant MD, Agarkar M, Marbella AM, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade: A Report by the American Society of Anesthesiologists Task Force on Neuromuscular Blockade. Anesthesiology. 2023 Jan 1;138(1):13-41. doi: 10.1097/ALN.0000000000004379. PubMed 36520073 ↗
  • Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15. PubMed 36377554 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06238219
Lead sponsor
Erasme University Hospital
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Apr 17, 2024
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 19, 2024

Study contacts

Denis Schmartz, MD
Contact
denis.schmartz@hubruxelles.be
+3225553919
Andréa Gardon, MD
Contact
andrea.gardon@hubruxelles.be
+3225553919

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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