Intensive Care Unit SedationNCT07239687
A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients
An observational study of Intensive Care Unit Sedation and Sedation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Sedation, Sedation, Target Controlled Infusion of Propofol
- What is being tested?
- propofol and TCI Propofol Injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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,
Show all 12Show fewer
- 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)
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
About this study
Official title: 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.
- Being tested
- propofol, TCI Propofol Injection
- Keywords
- Propofol, Target-Controlled Infusion, Eleveld Model, Schnider Model, ICU, Sedation, BIS, Riker Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Diprivan
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.
TCI Propofol InjectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: propofol; Device: TCI Propofol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: During the sedation period (up to 72 hours)
Secondary outcomes (1)
Proportion of Time Within Target Sedation Range (Riker Score 3-4)
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.
Measured: During the sedation period (up to 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Feb 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SedationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Özdemir Şimşek, Hacettepe University
- Investigators
- BASAK AKCA, Associate Professor, Study director, Hacettepe University Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239687
- Sponsor's protocol ID
- 2024/15-02 (KA-24022)
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 10360845
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Eleveld and Schnider Models for Target-Controlled Infusion of Propofol in Intensive Care Unit Sedation
- ClinicalTrials.gov ID
- NCT07239687
- Acronym / sponsor ID
- 2024/15-02 (KA-24022)
- Keywords
- Propofol, Target-Controlled Infusion, Eleveld Model, Schnider Model, ICU, Sedation, BIS, Riker Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eleveld Model Group | – | Drug: propofol, Device: TCI Propofol InjectionPatients 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 | – | Drug: propofol, Device: TCI Propofol InjectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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 -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: DiprivanPropofol 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. | Drug | Eleveld Model Group, Schnider Model Group |
| TCI Propofol InjectionPropofol 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. | Device | Eleveld Model Group, Schnider Model Group |
Primary outcome
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
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.
1 secondary outcome
Proportion of Time Within Target Sedation Range (Riker Score 3-4)
Time frame: During the sedation period (up to 72 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 10360845Schnider 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BASAK AKCA, Associate Professor study director
Hacettepe University Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Sedation and Sedation, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DUYGU OZDEMIR SIMSEK, MD (+905372916432, duyguozdemir94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Sedation Depth Control Measured by BIS Values (time frame: During the sedation period (up to 72 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07239687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.