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

D

Dr. Negrin University Hospital

Status

Enrolling

Conditions

Postoperative Complications
Postoperative Neuromuscular Block

Treatments

Diagnostic Test: Train-of-four

Study type

Observational

Funder types

Other

Identifiers

NCT06386354
2023-464-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

296 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

296 participants in 1 patient group

Patients submitted to General Anesthesia with Neuromuscular Block
Description:
Patients submitted to General Anesthesia with Neuromuscular Block
Treatment:
Diagnostic Test: Train-of-four

Trial contacts and locations

2

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Central trial contact

Aurelio Rodríguez Pérez, PhD; Ángel Becerra Bolaños, PhD

Data sourced from clinicaltrials.gov

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