NCT06238219

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 17, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

January 23, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

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.

    10 hours

Study Arms (1)

NMBA cohort

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

Drug: Neuromuscular Blocking Agent

Interventions

Administration of any neuromuscular blocking agent for surgery under general anesthesia

NMBA cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Incomplete electronic anesthesia record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire de Bruxelles - Hôpital erasme

Brussels, 1070, Belgium

RECRUITING

Related Publications (5)

  • 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.

    PMID: 30224322BACKGROUND
  • 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.

    PMID: 31607388BACKGROUND
  • 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.

    PMID: 31685216BACKGROUND
  • 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.

    PMID: 36520073BACKGROUND
  • 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.

    PMID: 36377554BACKGROUND

MeSH Terms

Interventions

Neuromuscular Blocking Agents

Intervention Hierarchy (Ancestors)

Neuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 2, 2024

Study Start

April 17, 2024

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations