Management of Neuromuscular Blocking Agents and Their Antagonism

Neuromuscular Monitoring Clinical Trial

— NMBA_periop  

Official title:

Clinical Practice Survey on the Management of Neuromuscular Blocking Agents and Their Antagonism During General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238219
• Other study ID #: SRB2024007
• Status: Recruiting
• Start date: April 17, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Erasme University Hospital
• Contact: Denis Schmartz, MD
• Phone: +3225553919
• Email: denis.schmartz[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Incomplete electronic anesthesia record

Related Conditions & MeSH terms

• Neuromuscular Blocking Agents
• Neuromuscular Monitoring

Intervention

Drug:
• Neuromuscular Blocking Agent
Administration of any neuromuscular blocking agent for surgery under general anesthesia

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire de Bruxelles - Hôpital erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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;: — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 hours