The influence of age on propofol pharmacodynamics.
T W Schnider, C F Minto, S L Shafer...
https://pubmed.ncbi.nlm.nih.gov/10360845Actively Recruiting
Age: 18Years +
All Genders
ID07239687
Comparison of Eleveld and Schnider Models for Target-Controlled Infusion of Propofol in Intensive Care Unit Sedation
Led by Hacettepe University · Updated on 2025-11-20
84
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two pharmacokinetic models, Eleveld and Schnider, for administering propofol sedation in mechanically ventilated patients in the intensive care unit (ICU). This observational study aims to assess which model better controls sedation depth, maintains hemodynamic stability, and supports faster recovery. The study uses sedation scales and monitoring tools like the Bispectral Index (BIS) and Riker Sedation-Agitation Scale to evaluate patient responses and safety. Participants will receive propofol through a target-controlled infusion (TCI) system guided by either the Eleveld or Schnider model. Sedation will be adjusted to maintain a Riker score between 3 and 4 and a BIS value between 60 and 80. Researchers will record hemodynamic variables, total propofol dosage, awakening time, and incidence of delirium after sedation withdrawal. No other sedatives or hypnotics will be used during sedation. During the study, patients will be monitored for sedation accuracy using BIS values for up to 72 hours. Assessments will include the proportion of time patients remain within the target sedation range. Data such as medical history, laboratory tests, and sedation depth will be collected and analyzed. The study will help identify the most reliable model for safe and effective sedation in ICU settings, with continuous monitoring of patient safety and sedation effects throughout the sedation period.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Classified as ASA physical status class I to IV
- Being monitored in the Anesthesiology and Reanimation Intensive Care Unit of Hacettepe University Faculty of Medicine Hospital
- Availability of necessary data such as medical history and laboratory results for analysis
- Hemodynamic stability
You will not qualify if you...
- Refusal to participate or lack of legal consent
- ASA physical status classification greater than IV
- Switching to an alternative sedation method during the study
- Contraindications to propofol infusion, including propofol allergy or lipid metabolism disorders
- Sedation level not assessable due to neurological or neurodegenerative diseases
- Expected sedation duration longer than 72 hours to reduce risk of propofol infusion syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 72 hours
Participants receive sedation with propofol administered via a target-controlled infusion (TCI) system guided by either the Eleveld or Schnider pharmacokinetic model. Sedation depth is carefully titrated and monitored to maintain target sedation levels.
Continuous monitoring during sedation period
Follow-up
Duration - Short-term post-sedation monitoring
Participants are observed for awakening time, hemodynamic parameters, and incidence of delirium after sedation ends to assess recovery and safety.
Approximately 1 to 2 visits depending on recovery
Trial Site Locations
Total: 1 location
1
Hacettepe University
Ankara, Turkey (Türkiye)
Actively Recruiting
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Research Team
D
DUYGU OZDEMIR SIMSEK, MD
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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