Neuromuscular Blocking Agents in Cardiac Surgery

NCT06595277 | Completed

• 1 other identifier: SRB2024216
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Background:
2. 2.Objectives of the clinical research project:
3. 3.Methodology of the clinical research project:
4. 4.Design of the clinical research project:
5. 5.Participants:

Conditions

Cardiac Surgery; Neuromuscular Blocking Agents

Keywords

cardiac surgery; neuromuscular transmission; neuromuscular blocking agents

Outcome Measures

Primary Outcomes (1)

• Concordance with current guidelines

  Percentage of patients (%) where neuromuscular management by ICU staff is in concordance with current guidelines for neuromuscular blocking agents.

  12 hours

Secondary Outcomes (1)

• TOF ratio at scheduled extubation

  12 hours

Study Arms (1)

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.

Diagnostic Test: Neuromuscular blockade

Interventions

Neuromuscular blockade DIAGNOSTIC_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.

Cardiac surgery with NMBA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing cardiac surgery at Hôpital Érasme between October 1, 2024 and May 31, 2025.

You may qualify if:

• Patients aged 18 and over
• Patients scheduled for cardiac surgery using a neuromuscular blocker
• Written informed consent

You may not qualify if:

• Absence of consent
• Minor patients

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

H.U.B - Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (5)

• 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.

  PMID: 37345870 BACKGROUND

• 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: 30224322 BACKGROUND

• 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: 36377554 BACKGROUND

• 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: 36520073 BACKGROUND

• Hemmerling 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.

  PMID: 18603747 BACKGROUND

MeSH Terms

Interventions

Muscle Relaxation

Intervention Hierarchy (Ancestors)

Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Denis Schmartz, MD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: November 5, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 15, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)