Cardiac SurgeryNCT06595277
Neuromuscular Blocking Agents in Cardiac Surgery
An observational study of Cardiac Surgery and Neuromuscular Blocking Agents, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
1. Background: Neuromuscular blocking agents (NMBA) are commonly used in cardiac surgery anesthesia to facilitate airway management and ventilation, and ensure optimal operative conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Neuromuscular Blocking Agents
- What is being tested?
- Neuromuscular blockade
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Nov 2024to 15 May 2025
- 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 cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025.
Who may be able to join
- Patients aged 18 and over
- Patients scheduled for cardiac surgery using a neuromuscular blocker
- Written informed consent
Who cannot join
- Absence of consent
- Minor patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Clinical Practices for the Management of Neuromuscular Blocking Agents in Cardiac Surgery
- Background: Neuromuscular blocking agents (NMBA) are commonly used in cardiac surgery anesthesia to facilitate airway management and ventilation, and ensure optimal operative conditions. To improve post-operative results and reduce the length of stay in the intensive care unit, the concept of "Fast track anesthesia" is coming into force, which includes all techniques that offer extubation within 1-6 hours post-operatively. Fast-track cardiac surgery is only feasible when short-acting NMBA are used and neuromuscular transmission has returned to normal by the end of the operation or just before extubation, a few hours after surgery. This requires quantitative monitoring of muscle strength, the only way to eliminate residual paralysis defined by a TOF ratio ≥ 0.9. The American Society of Anesthesiologists (ASA) and the European Society of Anesthesiology and Intensive Care (EASIC) recommend quantitative measurement of neuromuscular block until extubation.This is the only way to avoid the complications of residual paralysis, essentially postoperative pulmonary complications. The POPULAR study clearly highlighted the shortcomings of current NMBA management: out of a total population of 17150 patients, only 16.5% were extubated, with a TOF ratio greater than 0.90. Cardiac surgery patients are brought to the ICU still sedated, intubated and ventilated. Neuromuscular blocking agents are usually discontinued at the end of surgery. As awakening and extubation take place later in the ICU, clinicians often consider that the action of neuromuscular blocking agents is over, but without making a quantitative measurement as recommended by the guidelines.
- Objectives of the clinical research project: 2.1 Primary objective: The primary objective of this single-center prospective observational study is to systematically monitor the degree of postoperative curarization up to the time of extubation, and to assess the degree of adherence of intensive care teams to extubation recommendations based on quantitative measurements of the degree of neuromuscular junction block. 2.2 Secondary objectives: Quantify NMBA doses used, duration of action, duration of recovery.
- Methodology of the clinical research project: In this study, we will systematically check the degree of curarization of cardiac surgery patients up to the time of extubation. Prior to surgery, all patients will have an explanation of the protocol and will give written informed consent for the use of their data. Patient management is at the discretion of the anaesthetist in charge and will not be altered in any way by the protocol. All drugs used will be "standard of care". At the end of the procedure, one of the investigators will stay with the patient in intensive care and measure the degree of neuromuscular blockade with a curameter used as standard in clinical routine at Erasme Hospital (TOFScan, IdMed, Marseille, France). All measurements will be made in accordance with Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III. This measurement will be carried out continuously until the patient is extubated or 100% neuromuscular transmission has been recovered. ICU staff in charge of the patient will be blinded to the measurements done by the investigators. Intensive care physicians manage the patient according to the ICU standard of care. If the patient represents a residual curarization at the time of extubation, the investigators will inform the ICU staff in order to avoid endangering the patient. No intervention will be made with regard to the anesthesia and post-operative monitoring protocol; all medications and interventions will be considered "standard of care" and will be left to the discretion of the anesthesiologist and ICU team in charge.
- Design of the clinical research project: This is a prospective, observational study.
- Participants:
All patients undergoing cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025.
- Conditions
- Cardiac Surgery, Neuromuscular Blocking Agents
- Being tested
- Neuromuscular blockade
- Keywords
- cardiac surgery, neuromuscular transmission, neuromuscular blocking agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular blockadeDiagnostic test
Neuromuscular blockade will be measured in all patients using a quantitative measurement (TOFScan, IdMed, Marseille, France) during surgery and after surgery until either full neuromuscular recovery or time of scheduled extubation.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery with NMBA | All patients undergoing cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025 who receive any neuromuscular blocking agent. Receives: Diagnostic Test: Neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance with current guidelines
Percentage of patients (%) where neuromuscular management by ICU staff is in concordance with current guidelines for neuromuscular blocking agents.
Measured: 12 hours
Secondary outcomes (1)
TOF ratio at scheduled extubation
The train of four ratio (TOF ratio) will be measured at the time of scheduled extubation and its value recorded.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Nov 2024
- Primary completion10 May 2025
- Study completion15 May 2025
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 Cardiac SurgeryStudies 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
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Schmartz, MD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595277
- Sponsor's protocol ID
- SRB2024216
- Status last verified
- May 2025
- First submitted
- 10 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuchs-Buder T, Brull SJ, Fagerlund MJ, Renew JR, Cammu G, Murphy GS, Warle M, Vested M, Fulesdi B, Nemes R, Columb MO, Damian D, Davis PJ, Iwasaki H, Eriksson LI. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision. Acta Anaesthesiol Scand. 2023 Sep;67(8):994-1017. doi: 10.1111/aas.14279. Epub 2023 Jun 22.
PubMed 37345870Kirmeier 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 30224322Fuchs-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 36377554Thilen 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 36520073Hemmerling TM, Russo G, Bracco D. Neuromuscular blockade in cardiac surgery: an update for clinicians. Ann Card Anaesth. 2008 Jul-Dec;11(2):80-90. doi: 10.4103/0971-9784.41575.
PubMed 18603747
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Practices for the Management of Neuromuscular Blocking Agents in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06595277
- Acronym / sponsor ID
- SRB2024216
- Conditions
- Cardiac Surgery, Neuromuscular Blocking Agents
- Keywords
- cardiac surgery, neuromuscular transmission, neuromuscular blocking agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 19 Sep 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.
- Background: Neuromuscular blocking agents (NMBA) are commonly used in cardiac surgery anesthesia to facilitate airway management and ventilation, and ensure optimal operative conditions. To improve post-operative results and reduce the length of stay in the intensive care unit, the concept of "Fast track anesthesia" is coming into force, which includes all techniques that offer extubation within 1-6 hours post-operatively. Fast-track cardiac surgery is only feasible when short-acting NMBA are used and neuromuscular transmission has returned to normal by the end of the operation or just before extubation, a few hours after surgery. This requires quantitative monitoring of muscle strength, the only way to eliminate residual paralysis defined by a TOF ratio ≥ 0.9. The American Society of Anesthesiologists (ASA) and the European Society of Anesthesiology and Intensive Care (EASIC) recommend quantitative measurement of neuromuscular block until extubation.This is the only way to avoid the complications of residual paralysis, essentially postoperative pulmonary complications. The POPULAR study clearly highlighted the shortcomings of current NMBA management: out of a total population of 17150 patients, only 16.5% were extubated, with a TOF ratio greater than 0.90. Cardiac surgery patients are brought to the ICU still sedated, intubated and ventilated. Neuromuscular blocking agents are usually discontinued at the end of surgery. As awakening and extubation take place later in the ICU, clinicians often consider that the action of neuromuscular blocking agents is over, but without making a quantitative measurement as recommended by the guidelines.
- Objectives of the clinical research project: 2.1 Primary objective: The primary objective of this single-center prospective observational study is to systematically monitor the degree of postoperative curarization up to the time of extubation, and to assess the degree of adherence of intensive care teams to extubation recommendations based on quantitative measurements of the degree of neuromuscular junction block. 2.2 Secondary objectives: Quantify NMBA doses used, duration of action, duration of recovery.
- Methodology of the clinical research project: In this study, we will systematically check the degree of curarization of cardiac surgery patients up to the time of extubation. Prior to surgery, all patients will have an explanation of the protocol and will give written informed consent for the use of their data. Patient management is at the discretion of the anaesthetist in charge and will not be altered in any way by the protocol. All drugs used will be "standard of care". At the end of the procedure, one of the investigators will stay with the patient in intensive care and measure the degree of neuromuscular blockade with a curameter used as standard in clinical routine at Erasme Hospital (TOFScan, IdMed, Marseille, France). All measurements will be made in accordance with Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III. This measurement will be carried out continuously until the patient is extubated or 100% neuromuscular transmission has been recovered. ICU staff in charge of the patient will be blinded to the measurements done by the investigators. Intensive care physicians manage the patient according to the ICU standard of care. If the patient represents a residual curarization at the time of extubation, the investigators will inform the ICU staff in order to avoid endangering the patient. No intervention will be made with regard to the anesthesia and post-operative monitoring protocol; all medications and interventions will be considered "standard of care" and will be left to the discretion of the anesthesiologist and ICU team in charge.
- Design of the clinical research project: This is a prospective, observational study.
- Participants:
All patients undergoing cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery with NMBA | – | Diagnostic Test: Neuromuscular blockadeAll patients undergoing cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025 who receive any neuromuscular blocking agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025.
Key inclusion criteria (3 listed)
- Patients aged 18 and over
- Patients scheduled for cardiac surgery using a neuromuscular blocker
- Written informed consent
Key exclusion criteria (2 listed)
- Absence of consent
- Minor patients
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 blockadeNeuromuscular blockade will be measured in all patients using a quantitative measurement (TOFScan, IdMed, Marseille, France) during surgery and after surgery until either full neuromuscular recovery or time of scheduled extubation. | Diagnostic test | Cardiac surgery with NMBA |
Primary outcome
Concordance with current guidelines
Time frame: 12 hours
Percentage of patients (%) where neuromuscular management by ICU staff is in concordance with current guidelines for neuromuscular blocking agents.
1 secondary outcome
TOF ratio at scheduled extubation
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 37345870Fuchs-Buder T, Brull SJ, Fagerlund MJ, Renew JR, Cammu G, Murphy GS, Warle M, Vested M, Fulesdi B, Nemes R, Columb MO, Damian D, Davis PJ, Iwasaki H, Eriksson LI. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision. Acta Anaesthesiol Scand. 2023 Sep;67(8):994-1017. doi: 10.1111/aas.14279. Epub 2023 Jun 22.
- 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 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.
- 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 18603747Hemmerling TM, Russo G, Bracco D. Neuromuscular blockade in cardiac surgery: an update for clinicians. Ann Card Anaesth. 2008 Jul-Dec;11(2):80-90. doi: 10.4103/0971-9784.41575.
- 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.
Denis Schmartz, MD principal investigator
Université Libre de Bruxelles
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 Cardiac Surgery and Neuromuscular Blocking Agents, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance with current guidelines (time frame: 12 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 NCT06595277, 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 21 May 2025.