- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06238219
Management of Neuromuscular Blocking Agents and Their Antagonism (NMBA_periop)
Clinical Practice Survey on the Management of Neuromuscular Blocking Agents and Their Antagonism During General Anesthesia
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Denis Schmartz, MD
- Phone Number: +3225553919
- Email: denis.schmartz@hubruxelles.be
Study Contact Backup
- Name: Andréa Gardon, MD
- Phone Number: +3225553919
- Email: andrea.gardon@hubruxelles.be
Study Locations
-
-
-
Brussels, Belgium, 1070
- Recruiting
- Hôpital Universitaire de Bruxelles - Hôpital erasme
-
Contact:
- Denis Schmartz, MD
- Phone Number: +3225553919
- Email: denis.schmartz@hubruxelles.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients undergoing surgery with use of neuromuscular blocking agents at our institution
Exclusion Criteria:
- Incomplete electronic anesthesia record
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NMBA cohort
Patients undergoing surgery under general anesthesia with use of neuromuscular blocking agents
|
Administration of any neuromuscular blocking agent for surgery under general anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to ASA and ESAIC guidelines for the use and monitoring of neuromuscular bocking agents (%)
Time Frame: 10 hours
|
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.
|
10 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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. 2018 Nov 6;:
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRB2024007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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