Prediction of Propofol Effect Compartment Concentrations

NCT05940142 | Unknown

• 1 other identifier: SF44
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Analysis of Anaesthesia Depth

Outcome Measures

Primary Outcomes (2)

• 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)).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients meeting the inclusion and exclusion criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead

Study Sites (1)

Klinische Abteilung für Anästhesie und Intensivmedizin

Krems, Lower Austria, 3500, Austria

RECRUITING

Central Study Contacts

Robert Fritze, MD

CONTACT

++43/2732/9004-14055; Robert.Fritze@krems.lknoe.at

Study Design

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

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: July 11, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: July 11, 2023

Record last verified: 2023-05

Locations

AU (1)