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

NCT06325033 | Completed

• 1 other identifier: 18546
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Deep Sedation

Keywords

Procedural sedation; Propofol; Validation; Eleveld model

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of propofol infusion until end of propofol infusion, assessed for a maximum of 8 hours

Secondary Outcomes (3)

• Induction time

  From start of propofol infusion until introduction of endoscope, assessed for a maximum of 20 minutes.tart of the sedation.

• Recovery time

  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

  From start of propofol infusion until discharge from the recovery room, assessed for a maximum of 10 hours.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 29661412 RESULT

• Vellinga 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.

  PMID: 33317804 RESULT

• Xi 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.

  PMID: 29920532 RESULT

Study Officials

• Mendy Driesens, MSc

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 22, 2024
• Study Start: January 17, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)