Neuromuscular Blocking AgentsNMBA_periopNCT06238219
Management of Neuromuscular Blocking Agents and Their Antagonism
An observational study of Neuromuscular Blocking Agents and Neuromuscular Monitoring, run by Erasme University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blocking Agents, Neuromuscular Monitoring
- What is being tested?
- Neuromuscular Blocking Agent
- How many people
- 3,000 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgery with use of neuromuscular blocking agents at our institution from 2018 to 2023.
Who may be able to join
- All patients undergoing surgery with use of neuromuscular blocking agents at our institution
Who cannot join
- Incomplete electronic anesthesia record
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire de Bruxelles - Hôpital erasme
Brussels, 1070
Denis Schmartz, MD, +3225553919, denis.schmartz@hubruxelles.be
About this study
Official title: 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.
- Being tested
- Neuromuscular Blocking Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Blocking AgentDrug
Administration of any neuromuscular blocking agent for surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| NMBA cohort | Patients undergoing surgery under general anesthesia with use of neuromuscular blocking agents Receives: Drug: Neuromuscular Blocking Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start17 Apr 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blocking AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238219
- Sponsor's protocol ID
- SRB2024007
- Acronym
- NMBA_periop
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30224322Blobner 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 31607388Fuchs-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 31685216Thilen 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 36520073Fuchs-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
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practice Survey on the Management of Neuromuscular Blocking Agents and Their Antagonism During General Anesthesia
- ClinicalTrials.gov ID
- NCT06238219
- Acronym / sponsor ID
- NMBA_periop / SRB2024007
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMBA cohort | – | Drug: Neuromuscular Blocking AgentPatients undergoing surgery under general anesthesia with use of neuromuscular blocking agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery with use of neuromuscular blocking agents at our institution from 2018 to 2023.
Key inclusion criteria (1 listed)
- All patients undergoing surgery with use of neuromuscular blocking agents at our institution
Key exclusion criteria (1 listed)
- Incomplete electronic anesthesia record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Blocking AgentAdministration of any neuromuscular blocking agent for surgery under general anesthesia | Drug | NMBA cohort |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 30224322Kirmeier 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.
- Background: PubMed 31607388Blobner 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.
- Background: PubMed 31685216Fuchs-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.
- Background: PubMed 36520073Thilen 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.
- Background: PubMed 36377554Fuchs-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blocking Agents and Neuromuscular Monitoring, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (+3225553919, denis.schmartz@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to ASA and ESAIC guidelines for the use and monitoring of neuromuscular bocking agents (%) (time frame: 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238219, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.