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

Recruiting

• Conditions: Postoperative Neuromuscular Block; Postoperative Complications

• Registration Number: NCT06386354
• Lead Sponsor: Dr. Negrin University Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Study Start: 2024-05-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-24
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 296

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual Neuromuscular Block	8 minutes postoperatively	Train-Of-Four ratio 3 minutes after the arrival to the Post-Anesthetic Care Unit

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days postoperatively	Postoperative complications during hospital admission

Trial Locations

Locations (2)

Hospital Universitario de Gran Canaria Doctor Negrín; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain

Ángel Becerra; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain