Analysis of Anaesthesia DepthPropo2022NCT05940142
Prediction of Propofol Effect Compartment Concentrations
An observational study of Analysis of Anaesthesia Depth, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analysis of Anaesthesia Depth
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients meeting the inclusion and exclusion criteria
Who may be able to join
- Age of 18 or older at the time of the signature of the informed consent
- Signed informed consents
- Planned TIVA with Propofol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Klinische Abteilung für Anästhesie und Intensivmedizin
Krems, Lower Austria, 3500
Robert Fritze, MD, ++43/2732/9004-14055, Robert.Fritze@krems.lknoe.at
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral BIS values (derived from EEG)
Comparison of Predicted and Measured EEG values (recorded every five seconds)
Measured: 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)
Measured: During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analysis of Anaesthesia DepthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940142
- Sponsor's protocol ID
- SF44
- Acronym
- Propo2022
- Status last verified
- May 2023
- First submitted
- 14 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Propofol Effect Compartment Concentrations
- ClinicalTrials.gov ID
- NCT05940142
- Acronym / sponsor ID
- Propo2022 / SF44
- Conditions
- Analysis of Anaesthesia Depth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- Age of 18 or older at the time of the signature of the informed consent
- Signed informed consents
- Planned TIVA with Propofol
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bilateral BIS values (derived from EEG)
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analysis of Anaesthesia Depth, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Fritze, MD (++43/2732/9004-14055, Robert.Fritze@krems.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral BIS values (derived from EEG) (time frame: During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.