Actively Recruiting
A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients
Led by Hacettepe University · Updated on 2025-11-20
84
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hacettepe University
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
D
DUYGU OZDEMIR SIMSEK, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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