Menu
Recruiting NCT07239687

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

— Observational Intensive Care Unit Sedation Sedation Target Controlled Infusion of Propofol

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: propofol, TCI Propofol Injection.
Who it may be relevant to
Registry conditions: Intensive Care Unit Sedation, Sedation, Target Controlled Infusion of Propofol. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Eleveld and Schnider Models for Target-Controlled Infusion of Propofol in Intensive Care Unit Sedation

Overview

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.

Interventions

  • Drug propofol
    Propofol will be administered via a target-controlled infusion (TCI) system for sedation of mechanically ventilated ICU patients. Two pharmacokinetic models, Eleveld and Schnider, will be used to guide the infusion. Sedation depth will be titrated to achieve a Riker Sedation-Agitation Scale score between 3 and 4 and a Bispectral Index (BIS) value of 60-80. Hemodynamic parameters, total propofol dose, awakening time, and incidence of delirium will be recorded for comparison between models. No oth
  • Device TCI Propofol Injection
    Propofol will be administered intravenously via a target-controlled infusion (TCI) system for sedation of mechanically ventilated intensive care unit (ICU) patients. The infusion will be guided by two different pharmacokinetic models - Eleveld and Schnider - assigned to respective patient groups. The TCI device automatically adjusts infusion rates to maintain target effect-site concentrations according to each model. Sedation depth will be titrated to maintain a Riker Sedation-Agitation Scale sc

Primary outcome measures

  • Accuracy of Sedation Depth Control Measured by BIS Values [Time frame: During the sedation period (up to 72 hours)]
  • Accuracy of Sedation Depth Control Measured by BIS Values [Time frame: During the sedation period (up to 72 hours)]
Secondary outcome measures (1)
  • Proportion of Time Within Target Sedation Range (Riker Score 3-4) [Time frame: During the sedation period (up to 72 hours)]

Eligibility 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)

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University — Ankara

Publications

  • Schnider TW, Minto CF, Shafer SL, Gambus PL, Andresen C, Goodale DB, Youngs EJ. The influence of age on propofol pharmacodynamics. Anesthesiology. 1999 Jun;90(6):1502-16. doi: 10.1097/00000542-199906000-00003. PMID 10360845

Identifiers

NCT: NCT07239687 · 2024/15-02 (KA-24022)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗