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A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients

Recruitingn/aAges 18 Years - anyAllHacettepe University
NCT07239687 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective observational study aims to compare the clinical performance of two target-controlled infusion (TCI) models, Eleveld and Schnider, for propofol sedation in mechanically ventilated intensive care unit (ICU) patients. The study evaluates sedation depth, hemodynamic stability, and recovery profiles using the Bispectral Index (BIS) and Riker Sedation-Agitation Scale. Secondary outcomes include awakening time, total propofol dose, and incidence of delirium after sedation withdrawal. The findings may help identify the most reliable pharmacokinetic model for safe and effective ICU sedation.

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📋 Eligibility rules (as published)
Inclusion Criteria: Age over 18 years, Classified as ASA (American Society of Anesthesiologists physical status) class I-IV, Being monitored in the Anesthesiology and Reanimation Intensive Care Unit of Hacettepe University Faculty of Medicine Hospital, Availability of necessary data (medical history, laboratory results, etc.) for analysis, Hemodynamic stability - Exclusion Criteria:Patients who refused to participate in the study or did not provide legal consent, Patients with an ASA (American Society of Anesthesiologists physical status) classification greater than IV, Transition to an alternative sedation method during the study, Contraindication to propofol infusion (e.g., propofol anaphylaxis, lipid metabolism disorders), Patients whose sedation level could not be clinically assessed due to neurological or neurodegenerative diseases, Patients expected to require sedation for more than 72 hours (to reduce the risk of propofol infusion syndrome) \-
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What it tests

  • propofol
  • TCI Propofol Injection
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Where

1 site
Hacettepe University
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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