Clinical Trial

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

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Record status
This record was last updated November 20, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07239687
Lead Sponsor Hacettepe University
Conditions Intensive Care Unit Sedation, Sedation, Target Controlled Infusion of Propofol
Enrollment 84 participants
Start Date 2025-02-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-20