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

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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

NCT07239687•Hacettepe University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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)
•\-

Locations (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Key Dates

Start Date

February 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

January 1, 2026

Last Updated

November 20, 2025

Enrollment

ESTIMATED participants

Conditions

Intensive Care Unit SedationSedationTarget Controlled Infusion of Propofol

Interventions

propofol

DRUG

TCI Propofol Injection

DEVICE

Contacts

DUYGU OZDEMIR SIMSEK, MD

CONTACT

+905372916432 duyguozdemir94@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.

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