NCT06386354

Brief Summary

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

April 23, 2024

Last Update Submit

August 19, 2025

Conditions

Keywords

General AnesthesiaNeuromuscular block

Outcome Measures

Primary Outcomes (2)

  • Residual Neuromuscular Block

    Train-Of-Four ratio at arrival to the Post-Anesthetic Care Unit

    5 minutes postoperatively

  • Residual Neuromuscular Block

    Train-Of-Four ratio 3 minutes after the arrival to the Post-Anesthetic Care Unit

    8 minutes postoperatively

Secondary Outcomes (1)

  • Postoperative complications

    30 days postoperatively

Study Arms (1)

Patients submitted to General Anesthesia with Neuromuscular Block

Patients submitted to General Anesthesia with Neuromuscular Block

Diagnostic Test: Train-of-four

Interventions

Train-of-fourDIAGNOSTIC_TEST

Patients submitted to general anesthesia with neuromuscular block will be monitored at their arrival to the Post-Anesthesia Care Unit to assess the presence of residual neuromuscular block.

Patients submitted to General Anesthesia with Neuromuscular Block

Eligibility Criteria

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

Patients undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time.

You may qualify if:

  • Patient undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time and that required hospital admission.
  • Informed consent signature.

You may not qualify if:

  • Neuromuscular disease
  • Not having received neuromuscular block during the intervention
  • Admission to the outpatient surgery unit
  • Admission to the postoperative intensive care unit
  • Patients who signed informed consent, but postoperative data could not be collected upon arrival at the PACU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

RECRUITING

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Neuromuscular Monitoring

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ángel Becerra Bolaños, PhD

CONTACT

Aurelio Rodríguez Pérez, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 26, 2024

Study Start

May 1, 2024

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations