Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications

NCT ID: NCT06386354

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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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. In this prospective observational study, all patients who underwent general anesthesia with neuromuscular blockade were studied consecutively to evaluate the presence of residual neuromuscular blockade and its potential consequences during hospital admission.Considering that the percentage of residual curarization is 19% (PORCzero study), with a 95% confidence interval and a 3% error margin, 236 patients are needed to accurately estimate the prevalence of residual curarization in the study population. With an expected loss proportion of 20%, the chosen sample size is 296 patients.

Conditions

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Postoperative Neuromuscular Block Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients submitted to General Anesthesia with Neuromuscular Block

Patients submitted to General Anesthesia with Neuromuscular Block

Train-of-four

Intervention Type DIAGNOSTIC_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.

Interventions

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Train-of-four

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ángel Becerra-Bolaños, MD PhD

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status RECRUITING

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ángel Becerra Bolaños, PhD

Role: CONTACT

+34928450370

Aurelio Rodríguez Pérez, PhD

Role: CONTACT

+34928450370

Facility Contacts

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Angel Becerra Bolaños, MD PhD

Role: primary

+34928450370

Aurelio E Rodríguez Pérez, MD PhD

Role: backup

+34928450370

Ángel Becerra, MD

Role: primary

+34676229025

Role: backup

Other Identifiers

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2023-464-1

Identifier Type: -

Identifier Source: org_study_id

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