Prediction of Propofol Effect Compartment Concentrations

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05940142

Acronym

Propo2022

Enrollment

150

Registered

2023-07-11

Start date

2023-05-01

Completion date

2025-05-31

Last updated

2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analysis of Anaesthesia Depth

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Austria

Contacts

Primary ContactRobert Fritze, MD

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

Outcome results