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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 -

Locations
Other Locations
Turkey
Hacettepe University
RECRUITING
Ankara
Contact Information
Primary
DUYGU OZDEMIR SIMSEK, MD
duyguozdemir94@gmail.com
+905372916432
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 84
Treatments
Eleveld Model Group
Patients sedated with propofol using the Eleveld pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation will be titrated to maintain a Riker Sedation-Agitation Scale score between 3 and 4 and a Bispectral Index (BIS) value of 60-80. Hemodynamic variables, awakening time, and total propofol dose will be recorded for comparison with the Schnider group.
Schnider Model Group
Patients sedated with propofol using the Schnider pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation depth and hemodynamic parameters will be monitored using the same protocol as in the Eleveld group. BIS values, Riker scores, and recovery profiles will be compared to assess pharmacodynamic and clinical performance between models.
Related Therapeutic Areas
Sponsors
Leads: Hacettepe University

This content was sourced from clinicaltrials.gov