A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients
Comparison of Eleveld and Schnider Models for Target-Controlled Infusion of Propofol in Intensive Care Unit Sedation
Hacettepe University
84 participants
Feb 1, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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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Interventions
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 other sedative or hypnotic agents will be used during the study period.
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 score of 3-4 and a Bispectral Index (BIS) value between 60 and 80. Hemodynamic variables, awakening time, and delirium incidence will be evaluated to compare clinical performance between the two models.
Locations(1)
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NCT07239687