Comparing two propofol dosing models for sedated ICU patients on ventilators
Official title: Comparison of Eleveld and Schnider Models for Target-Controlled Infusion of Propofol in Intensive Care Unit Sedation
Run by Hacettepe University · NCT07239687 · Data updated 2026-11-12
This study will test whether the Eleveld or Schnider dosing model gives steadier propofol sedation for adults on mechanical ventilation in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | December 1, 2025 |
| Study ends | January 1, 2026 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07239687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) who are ASA class I–IV, mechanically ventilated and monitored in the Hacettepe University Anesthesiology and Reanimation ICU, hemodynamically stable, able to provide necessary clinical data, and expected to require sedation under 72 hours are eligible.
✕Probably not a fit
Patients with contraindications to propofol, severe neurological or neurodegenerative conditions preventing clinical sedation assessment, ASA > IV, those expected to need sedation beyond 72 hours, or those who switch to a different sedation method are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study compares clinical performance of the Eleveld and Schnider target-controlled infusion (TCI) models for propofol in mechanically ventilated adults. Sedation depth will be monitored with the Bispectral Index (BIS) and the Riker Sedation-Agitation Scale while routine hemodynamic parameters are recorded. Secondary measures include awakening time after sedation withdrawal, total propofol dose administered, and incidence of delirium. Patients are enrolled from a single tertiary ICU and receive TCI propofol per clinical practice, with data collected for up to 72 hours of sedation.
Why it matters
Potential benefit: If one model produces more stable sedation with fewer blood pressure or heart rate swings and faster recovery, clinicians could use it to improve safety and shorten ICU recovery time.
How similar studies have gone: Comparisons of Schnider and newer population models like Eleveld have been performed in operating-room and healthy-population settings with mixed results, but robust ICU-specific evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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) \-
Where it's running
-
Hacettepe University
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Duygu Ozdemir Simsek, Md
- Email: duyguozdemir94@gmail.com
- Phone: +905372916432
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.