Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults.

September 15, 2025 updated by: University Medical Center Groningen

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

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

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700
        • University Medical Center Groningen

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Three groups of 25 adult patients each, undergoing a diagnostic of interventional procedure at the endoscopy suite under procedural sedation.

Description

Inclusion Criteria:

  • Adult patients for procedural sedation in the UMCG between 01-01-2024 and 01-01-2025.

Exclusion Criteria:

  • Age <18 years; use of esketamine during the procedure, use of benzodiazepines prior or during the procedure, hearing disability, BIS quality index < 50

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From start of propofol infusion until end of propofol infusion, assessed for a maximum of 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction time
Time Frame: From start of propofol infusion until introduction of endoscope, assessed for a maximum of 20 minutes.tart of the sedation.
Time from start of propofol infusion to introduction of the endoscope.
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.
The time to reach MOAAS 5 after having stopped target controlled infusion of propofol.
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.
The use of vasopressors such as ephedrine, phenylephrine or norepinephrine. The need for airway maneuvers such as chin lift, jaw thrust or nasopharyngeal airway.
From start of propofol infusion until discharge from the recovery room, assessed for a maximum of 10 hours.

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Mendy Driesens, MSc, University Medical Center Groningen

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)

January 17, 2024

Primary Completion (Actual)

July 11, 2024

Study Completion (Actual)

July 11, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18546

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

No

Studies a U.S. FDA-regulated device product

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.

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