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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Postoperative Neuromuscular Block
• Intervention / Treatment: Diagnostic test: Train-of-four

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.

• Study Type: Observational
• Enrollment (Estimated): 296

Contacts and Locations

• Study Contact: Name: Ángel Becerra Bolaños, PhD; Phone Number: +34928450370; Email: angbecbol@gmail.com
• Study Contact Backup: Name: Aurelio Rodríguez Pérez, PhD; Phone Number: +34928450370; Email: arodperp@gobiernodecanarias.org

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Recruiting
      • Ángel Becerra
      • Contact: Email: angbecbol@gmail.com
      • Contact: Ángel Becerra, MD; Phone Number: +34676229025; Email: angbecbol@gmail.com
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35010
      • Recruiting
      • Hospital Universitario de Gran Canaria Doctor Negrín
      • Contact: Angel Becerra Bolaños, MD PhD; Phone Number: +34928450370; Email: angbecbol@gmail.com
      • Contact: Aurelio E Rodríguez Pérez, MD PhD; Phone Number: +34928450370; Email: arodperp@gobiernodecanarias.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients submitted to General Anesthesia with Neuromuscular Block	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications during hospital admission	30 days postoperatively

Collaborators and Investigators

• Sponsor: Dr. Negrin University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: General Anesthesia; Neuromuscular block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 2023-464-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No