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

November 16, 2025 updated by: Duygu Özdemir Şimşek, Hacettepe University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 who refused to participate in the study or did not provide legal consent,

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)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Diprivan
Device: TCI Propofol Injection
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.
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
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.
Other Names:
  • Diprivan
Device: TCI Propofol Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Sedation Depth Control Measured by BIS Values
Time Frame: During the sedation period (up to 72 hours)
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
Time Frame: During the sedation period (up to 72 hours)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Time Within Target Sedation Range (Riker Score 3-4)
Time Frame: During the sedation period (up to 72 hours)
Percentage of total sedation time during which patients remained within the target Riker Sedation-Agitation Scale (SAS) range of 3-4, comparing the Eleveld and Schnider TCI propofol models.
During the sedation period (up to 72 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: BASAK AKCA, Associate Professor, Hacettepe University Faculty of Medicine, Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/15-02 (KA-24022)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedation

Clinical Trials on propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe