What is this study trying to find out about sedation in intensive care unit patients?

This study compares two methods of delivering propofol sedation in ICU patients to see which better controls sedation depth and recovery. Researchers are evaluating clinical performance using sedation scales and monitoring tools. The study is conducted at Hacettepe University to improve sedation safety and effectiveness in ICU care.

Who may be eligible for this intensive care unit sedation clinical trial?

Adults aged 18 years or older who are monitored in the ICU and classified as ASA physical status class I to IV may be eligible. Participants must not have contraindications to propofol and should have stable hemodynamics. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this intensive care unit sedation clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Age: 18Years +

All Genders

ID07239687

Comparing Eleveld and Schnider Models for Propofol Sedation in ICU Patients Using Target-Controlled Infusion

Led by Hacettepe University · Updated on 2025-11-20

Participants Needed

Research Sites

4 weeks

Total Duration

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

Research Team

DUYGU OZDEMIR SIMSEK, MD

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