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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Sponsor: University Medical Centre Ljubljana
Summary
Most patients resuscitated from out-of-hospital cardiac arrest (OHCA) remain comatose on hospital admission and are routinely managed with continuous sedation. Sedation facilitates temperature control, but deep and prolonged sedation is associated with longer mechanical ventilation, delirium, infections and delayed awakening. It is unknown whether minimizing sedation increases secondary hypoxic-ischemic brain injury. This single-centre, open-label, randomized non-inferiority trial will compare a minimal sedation strategy (no continuous sedation) with standard continuous sedation in 100 comatose adults after OHCA. The primary outcome is serum neuron-specific enolase (NSE) 72 hours after return of spontaneous circulation (ROSC). Secondary outcomes include in-hospital mortality, neurological outcome at discharge, duration of mechanical ventilation and length of ICU stay.
Official title: Effect of Early Discontinuation of Sedation on Biomarkers of Hypoxic-Ischemic Brain Injury After Out-of-Hospital Cardiac Arrest: A Prospective Randomized Non-Inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09-22
Completion Date
2028-10
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Minimal sedation
Sedation-minimizing strategy without continuous sedation: continuous sedation is not started or is stopped immediately after randomization; short-acting sedatives only when clinically required, at the lowest dose for the shortest time; analgesia maintained throughout.
Standard continuous sedation
Continuous sedation with propofol (first choice) and continuous analgesia with sufentanil (first choice) for at least 36 hours after cardiac arrest, titrated to PSI 25-50 or BIS 40-60; after 36 hours, sedation may be discontinued at the discretion of the treating physician.
Locations (1)
University Medical Centre Ljubljana, Department of Intensive Internal Medicine
Ljubljana, Slovenia