Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Train-of-four.
- Who it may be relevant to
- Registry conditions: Postoperative Neuromuscular Block, Postoperative Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Primary outcome measures
- Residual Neuromuscular Block [Time frame: 5 minutes postoperatively]
- Residual Neuromuscular Block [Time frame: 8 minutes postoperatively]
Secondary outcome measures (1)
- Postoperative complications [Time frame: 30 days postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria
- Ángel Becerra — Las Palmas de Gran Canaria
Identifiers
NCT: NCT06386354 · 2023-464-1