Prediction of Propofol Effect Compartment Concentrations | NCT05940142

Studies
Prediction of Propofol Effect Compartment Concentrations

NCT05940142

Sponsor

Karl Landsteiner University of Health Sciences

Status

Unknown status

Last Update Posted

Jul 11, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Analysis of Anaesthesia Depth

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

May 31, 2025Estimated

First Submitted Date

May 14, 2023

First Submission Date that Met QC Criteria

Jul 10, 2023

First Posted Date

Jul 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2023

Last Update Posted Date

Jul 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients meeting the inclusion and exclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert Fritze, MD	Contact	++43/2732/9004-14055		Robert.Fritze@krems.lknoe.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinische Abteilung für Anästhesie und Intensivmedizin	Recruiting	Krems	Lower Austria	3500	Austria