Deep SedationNCT06325033
Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults.
An observational study of Deep Sedation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation. The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Sedation
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jan 2024to 11 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three groups of 25 adult patients each, undergoing a diagnostic of interventional procedure at the endoscopy suite under procedural sedation.
Who may be able to join
- Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025.
Who cannot join
- Age <18 years; use of esketamine during the procedure, use of benzodiazepines prior or during the procedure, hearing disability, BIS quality index < 50
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Validation of the Eleveld Pharmacokinetic and Pharmacodynamic Model of Propofol for Procedural Sedation in Adults.
The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation.
The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring.
Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor.
Read the detailed description
Since 2012 procedural sedation practices in Dutch hospitals has taken a huge flight. Propofol is the preferred drug of choice for moderate to deep sedation. This can be titrated by using pharmacokinetic (PK) and pharmacodynamic (PD) models programmed in infusion pumps for target controlled infusion (TCI). Several pharmacokinetic-pharmacodynamic (PKPD) models for TCI propofol are available. While most TCI systems incorporate PK or PKPD models for specific patient groups such as adults, children or older patients, the Eleveld model has been developed for TCI of propofol for general anesthesia and sedation in a broad range of patients. In 2021 Vellinga et al published a study on the validation of the Eleveld model in patients undergoing general anesthesia. So far, the Eleveld model has not been externally validated for the use of procedural sedation in adult patients.
The aim of this study is to identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated bispectral index ( BIS) levels in adult patients.
The secondary outcomes are: time to introduction of the endoscope and the time to reach MOAAS 5 after having stopped TCI propofol. The use of vasopressors such as ephedrine, phenylephrine or norepinephrine. The need for airway maneuvers such as chin lift, jaw thrust or nasopharyngeal airway.
The purpose of this investigation is to produce normalizing graphs of propofol drug infusion and TCI target concentrations for clinical sedation using the Eleveld TCI model. It mirrors the validation study of the Eleveld model. The sample size estimation of that study was determined by estimation bounds of the model-based drug concentration prediction accuracy. That study used 25 individuals for four groups: children, non-obese, elderly, and obese adults. Aside from the determination of prediction accuracy of the Eleveld model, an important secondary result was normalizing graphs of target concentrations, drug infusion, and drug effects in clinical practice.
The intention of the current investigation is to reproduce the normalizing graphs of TCI targets, drug infusion and effects similar to the Eleveld propofol TCI model validation study, but targeted to sedation rather than anesthesia. The current investigation uses no blood samples so sample size estimation cannot be based on model-based drug concentration prediction accuracy. We determined that a sample size similar to the validation study is appropriate and propose allocating 25 patients per group and three groups: non-obese, elderly and obese adults, for a total of 75 individuals.
- Conditions
- Deep Sedation
- Keywords
- Procedural sedation, Propofol, Validation, Eleveld model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients age ≥ 18 - <65 and BMI <30 | Adult patients for procedural sedation in the University Medical Center Groningen (UMCG) between 01-01-2024 and 01-01-2025. | |
| Patients age ≥ 18 - <65 and BMI ≥ 30 | Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025. | |
| Patients age ≥ 65 and over | Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients.
The intention of the current investigation is to reproduce the normalizing graphs of TCI targets, drug infusion and effects similar to the Eleveld propofol TCI model validation study, but targeted to sedation rather than anesthesia.
Measured: From start of propofol infusion until end of propofol infusion, assessed for a maximum of 8 hours
Secondary outcomes (3)
Induction time
Time from start of propofol infusion to introduction of the endoscope.
Measured: From start of propofol infusion until introduction of endoscope, assessed for a maximum of 20 minutes.tart of the sedation.
Recovery time
The time to reach MOAAS 5 after having stopped target controlled infusion of propofol.
Measured: The time from stopping propofol infusion until reaching sedation and recovery level MOAAS 5 assessed or a maximum of up to 1 hour.
Adverse events
The use of vasopressors such as ephedrine, phenylephrine or norepinephrine. The need for airway maneuvers such as chin lift, jaw thrust or nasopharyngeal airway.
Measured: From start of propofol infusion until discharge from the recovery room, assessed for a maximum of 10 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start17 Jan 2024
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mendy Driesens, MSc, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325033
- Sponsor's protocol ID
- 18546
- Status last verified
- Sep 2025
- First submitted
- 8 Feb 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12.
PubMed 29661412Vellinga R, Hannivoort LN, Introna M, Touw DJ, Absalom AR, Eleveld DJ, Struys MMRF. Prospective clinical validation of the Eleveld propofol pharmacokinetic-pharmacodynamic model in general anaesthesia. Br J Anaesth. 2021 Feb;126(2):386-394. doi: 10.1016/j.bja.2020.10.027. Epub 2020 Dec 13.
PubMed 33317804Xi C, Sun S, Pan C, Ji F, Cui X, Li T. Different effects of propofol and dexmedetomidine sedation on electroencephalogram patterns: Wakefulness, moderate sedation, deep sedation and recovery. PLoS One. 2018 Jun 19;13(6):e0199120. doi: 10.1371/journal.pone.0199120. eCollection 2018.
PubMed 29920532
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Validation of the Eleveld Pharmacokinetic and Pharmacodynamic Model of Propofol for Procedural Sedation in Adults.
- ClinicalTrials.gov ID
- NCT06325033
- Acronym / sponsor ID
- 18546
- Conditions
- Deep Sedation
- Keywords
- Procedural sedation, Propofol, Validation, Eleveld model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 22 Mar 2024 (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.
The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation.
The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring.
Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor.
Detailed description
Since 2012 procedural sedation practices in Dutch hospitals has taken a huge flight. Propofol is the preferred drug of choice for moderate to deep sedation. This can be titrated by using pharmacokinetic (PK) and pharmacodynamic (PD) models programmed in infusion pumps for target controlled infusion (TCI). Several pharmacokinetic-pharmacodynamic (PKPD) models for TCI propofol are available. While most TCI systems incorporate PK or PKPD models for specific patient groups such as adults, children or older patients, the Eleveld model has been developed for TCI of propofol for general anesthesia and sedation in a broad range of patients. In 2021 Vellinga et al published a study on the validation of the Eleveld model in patients undergoing general anesthesia. So far, the Eleveld model has not been externally validated for the use of procedural sedation in adult patients.
The aim of this study is to identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated bispectral index ( BIS) levels in adult patients.
The secondary outcomes are: time to introduction of the endoscope and the time to reach MOAAS 5 after having stopped TCI propofol. The use of vasopressors such as ephedrine, phenylephrine or norepinephrine. The need for airway maneuvers such as chin lift, jaw thrust or nasopharyngeal airway.
The purpose of this investigation is to produce normalizing graphs of propofol drug infusion and TCI target concentrations for clinical sedation using the Eleveld TCI model. It mirrors the validation study of the Eleveld model. The sample size estimation of that study was determined by estimation bounds of the model-based drug concentration prediction accuracy. That study used 25 individuals for four groups: children, non-obese, elderly, and obese adults. Aside from the determination of prediction accuracy of the Eleveld model, an important secondary result was normalizing graphs of target concentrations, drug infusion, and drug effects in clinical practice.
The intention of the current investigation is to reproduce the normalizing graphs of TCI targets, drug infusion and effects similar to the Eleveld propofol TCI model validation study, but targeted to sedation rather than anesthesia. The current investigation uses no blood samples so sample size estimation cannot be based on model-based drug concentration prediction accuracy. We determined that a sample size similar to the validation study is appropriate and propose allocating 25 patients per group and three groups: non-obese, elderly and obese adults, for a total of 75 individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients age ≥ 18 - <65 and BMI <30 | – | –Adult patients for procedural sedation in the University Medical Center Groningen (UMCG) between 01-01-2024 and 01-01-2025. |
| Patients age ≥ 18 - <65 and BMI ≥ 30 | – | –Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025. |
| Patients age ≥ 65 and over | – | –Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups of 25 adult patients each, undergoing a diagnostic of interventional procedure at the endoscopy suite under procedural sedation.
Key inclusion criteria (1 listed)
- Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025.
Key exclusion criteria (1 listed)
- Age <18 years; use of esketamine during the procedure, use of benzodiazepines prior or during the procedure, hearing disability, BIS quality index < 50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients.
Time frame: From start of propofol infusion until end of propofol infusion, assessed for a maximum of 8 hours
The intention of the current investigation is to reproduce the normalizing graphs of TCI targets, drug infusion and effects similar to the Eleveld propofol TCI model validation study, but targeted to sedation rather than anesthesia.
3 secondary outcomes
Induction time
Time frame: From start of propofol infusion until introduction of endoscope, assessed for a maximum of 20 minutes.tart of the sedation.
Recovery time
Time frame: The time from stopping propofol infusion until reaching sedation and recovery level MOAAS 5 assessed or a maximum of up to 1 hour.
Adverse events
Time frame: From start of propofol infusion until discharge from the recovery room, assessed for a maximum of 10 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 29661412Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12.
- Results publication: PubMed 33317804Vellinga R, Hannivoort LN, Introna M, Touw DJ, Absalom AR, Eleveld DJ, Struys MMRF. Prospective clinical validation of the Eleveld propofol pharmacokinetic-pharmacodynamic model in general anaesthesia. Br J Anaesth. 2021 Feb;126(2):386-394. doi: 10.1016/j.bja.2020.10.027. Epub 2020 Dec 13.
- Results publication: PubMed 29920532Xi C, Sun S, Pan C, Ji F, Cui X, Li T. Different effects of propofol and dexmedetomidine sedation on electroencephalogram patterns: Wakefulness, moderate sedation, deep sedation and recovery. PLoS One. 2018 Jun 19;13(6):e0199120. doi: 10.1371/journal.pone.0199120. eCollection 2018.
- 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. This study is not recruiting at the moment.
Mendy Driesens, MSc principal investigator
University Medical Center Groningen
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 Deep Sedation, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients. (time frame: From start of propofol infusion until end of propofol infusion, assessed for a maximum of 8 hours). 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 NCT06325033, which also lists 3 linked publications.
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 19 Sep 2025.