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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06386354
Acronym
Porcerito
Enrollment
296
Registered
2024-04-26
Start date
2024-05-01
Completion date
2025-10-30
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Postoperative Neuromuscular Block

Keywords

General Anesthesia, Neuromuscular block

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTTrain-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.

Sponsors

Dr. Negrin University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Residual Neuromuscular Block5 minutes postoperativelyTrain-Of-Four ratio at arrival to the Post-Anesthetic Care Unit

Secondary

MeasureTime frameDescription
Postoperative complications30 days postoperativelyPostoperative complications during hospital admission

Countries

Spain

Contacts

Primary ContactÁngel Becerra Bolaños, PhD
angbecbol@gmail.com+34928450370
Backup ContactAurelio Rodríguez Pérez, PhD
arodperp@gobiernodecanarias.org+34928450370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026