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

NCT07239687 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: 2024/15-02 (KA-24022)
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intensive Care Unit Sedation; Sedation; Target Controlled Infusion of Propofol

Keywords

Propofol, Target-Controlled Infusion, Eleveld Model, Schnider Model, ICU, Sedation, BIS, Riker Scale

Outcome Measures

Primary Outcomes (2)

• Accuracy of Sedation Depth Control Measured by BIS Values

  Comparison of the accuracy and stability of target-controlled infusion (TCI) sedation between the Eleveld and Schnider pharmacokinetic models in mechanically ventilated ICU patients. Sedation depth will be assessed by Bispectral Index (BIS) monitoring and maintained between 60 and 80. The mean absolute deviation of BIS from target range will be calculated to evaluate model performance

  During the sedation period (up to 72 hours)

• Accuracy of Sedation Depth Control Measured by BIS Values

  Comparison of the accuracy and stability of target-controlled infusion (TCI) sedation between the Eleveld and Schnider pharmacokinetic models in mechanically ventilated ICU patients. Sedation depth will be assessed by Bispectral Index (BIS) monitoring and maintained between 60 and 80. The mean absolute deviation of BIS from target range will be calculated to evaluate model performance.

  During the sedation period (up to 72 hours)

Secondary Outcomes (1)

• Proportion of Time Within Target Sedation Range (Riker Score 3-4)

  During the sedation period (up to 72 hours)

Study Arms (2)

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.

Drug: propofol; Device: TCI Propofol Injection

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.

Drug: propofol; Device: TCI Propofol Injection

Interventions

propofol DRUG

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.

Also known as: Diprivan

Eleveld Model Group; Schnider Model Group

TCI Propofol Injection DEVICE

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.

Eleveld Model Group; Schnider Model Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (aged 18 years or older) admitted to the intensive care unit (ICU) who require continuous sedation with propofol during mechanical ventilation. All patients are hemodynamically stable at the time of sedation initiation and are expected to require sedation for at least 24 hours. Patients are managed according to standard ICU protocols, including daily sedation assessments and monitoring with the Bispectral Index (BIS) and Riker Sedation-Agitation Scale.

You may qualify if:

• 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 -

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Schnider TW, Minto CF, Shafer SL, Gambus PL, Andresen C, Goodale DB, Youngs EJ. The influence of age on propofol pharmacodynamics. Anesthesiology. 1999 Jun;90(6):1502-16. doi: 10.1097/00000542-199906000-00003.

  PMID: 10360845 RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• BASAK AKCA, Associate Professor

  Hacettepe University Faculty of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

DUYGU OZDEMIR SIMSEK, MD

CONTACT

+905372916432; duyguozdemir94@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical resident in anesthesiology

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)