Prediction of Propofol Effect Compartment Concentrations

Recruiting

• Conditions: Analysis of Anaesthesia Depth

• Registration Number: NCT05940142
• Lead Sponsor: Karl Landsteiner University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-01
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-07-10
• Last Update Submitted: 2023-07-10
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Klinische Abteilung für Anästhesie und Intensivmedizin; 🇦🇹 Krems, Niederösterreich, Austria