Predicting how Propofol affects anesthesia depth using EEG data
Prediction of Propofol Effect Compartment Concentrations
Karl Landsteiner University of Health Sciences · NCT05940142
This study is testing if new ways of analyzing brain activity can better predict how deep anesthesia goes when using Propofol during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karl Landsteiner University of Health Sciences (other) |
| Locations | 1 site (Krems, Niederösterreich) |
| Trial ID | NCT05940142 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate models that can accurately predict the effects of Propofol on anesthesia depth by analyzing EEG data collected during surgical procedures. Participants will undergo planned Total Intravenous Anesthesia (TIVA) with Propofol, and their EEG readings will be recorded to compare the effectiveness of new predictive models against existing ones, such as the Schnider model. The study seeks to enhance clinical practices in anesthesia management by identifying the most reliable prediction model.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are scheduled for surgeries requiring TIVA with Propofol.
Not a fit: Patients with contraindications to Propofol, those undergoing neurosurgical operations, or those requiring intensive care before or after surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more precise dosing of Propofol, improving patient safety and outcomes during anesthesia.
How similar studies have performed: While there have been studies on anesthesia depth prediction, this specific approach using EEG data for Propofol is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Krems, Niederösterreich
- Klinische Abteilung für Anästhesie und Intensivmedizin — Krems, Niederösterreich, Austria (RECRUITING)
Study contacts
- Study coordinator: Robert Fritze, MD
- Email: Robert.Fritze@krems.lknoe.at
- Phone: ++43/2732/9004-14055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Analysis of Anaesthesia Depth