Prediction of Propofol Effect Compartment Concentrations (Propo2022)

The goal of this observational study is to learn about the prediction of the effect of Propofol by means of EEGs. The main questions it aims to answer are:

• Develop models that can reliably predict the effect of Propofol
• Select the most well suited model for clinical practice
• Compare this model to already existing models (e.g. Schnider-model)

Participants will asked to allow us to collect and use the EEG data recorded during the operations.

Study Overview

• Status: Recruiting
• Conditions: Analysis of Anaesthesia Depth

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Robert Fritze, MD; Phone Number: ++43/2732/9004-14055; Email: Robert.Fritze@krems.lknoe.at

Study Locations

• Austria
  • Niederösterreich
    • Krems, Niederösterreich, Austria, 3500
      • Recruiting
      • Klinische Abteilung für Anästhesie und Intensivmedizin
      • Contact: Robert Fritze, MD; Phone Number: ++43/2732/9004-14055; Email: Robert.Fritze@krems.lknoe.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients meeting the inclusion and exclusion criteria

Description

Inclusion Criteria:

• Age of 18 or older at the time of the signature of the informed consent
• Signed informed consents
• Planned TIVA with Propofol

Exclusion Criteria:

• Use of extracorporal circulation (e.g., HLM, ECMO)
• Admission to an ICU/IMCU before the operation or planned admission to an ICU/IMCU after the operation
• Administration of Propofol seven days prior to the planned operation
• Missing informed consent
• All contraindications against TIVA (e.g., allergy against Propofol or soy)
• All operations where BIS monitoring cannot be used (e.g., skin lesions on the front)
• Patients for which the administration of Propofol could be potentially harmfull (e.g., severe heart failure with the risk of drop of blood pressure)
• Neurosurgical operations

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilateral BIS values (derived from EEG)	Comparison of Predicted and Measured EEG values (recorded every five seconds)	During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).
Propofol cumulative dose	Cumulative dose of Propofol (recorded every second)	During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).

Collaborators and Investigators

• Sponsor: Karl Landsteiner University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SF44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No