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Propo2022: Prediction of Propofol Effect Compartment Concentrations

Sponsor
Karl Landsteiner University of Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05940142
Collaborator
(none)
150
Enrollment
1
Location
25
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Propofol Effect Compartment Concentrations
    Actual Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    May 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Bilateral BIS values (derived from EEG) [During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).]

      Comparison of Predicted and Measured EEG values (recorded every five seconds)

    2. Propofol cumulative dose [During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).]

      Cumulative dose of Propofol (recorded every second)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinische Abteilung für Anästhesie und Intensivmedizin Krems Niederösterreich Austria 3500

    Sponsors and Collaborators

    • Karl Landsteiner University of Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karl Landsteiner University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05940142
    Other Study ID Numbers:
    • SF44
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 11, 2023