Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417645
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-11
Brief Title:
Re-evaluation of the Effect Site Model of the PKPD Propofol Eleveld Model
Sponsor:
Universidad del Desarrollo
Organization:
Universidad del Desarrollo
Study Overview
Official Title:
the BIS Index Response is Poorly Described by Propofol Effect Site Elevelds Model After Applying a Perturbation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Eleved PD
Brief Summary:
in healthy patients undergoing elective surgery after a very slow induction using Elevelds kinetics as a reference after loss of consciousness LOC and intubation proceed to infuse propofol until 1 burst suppression ratio is obtained Then return to the LOC concentration The BISindex predicted by the model and the real one will be evaluated The evolution of spectral density frequencies over time will also be evaluated
Detailed Description:
Eleveld is a recently developed PKPD model of propofol which includes multiple covariates in its pharmacokinetics
This model called Universal includes data from all studies conducted with plasma levels in the world where the principal investigator PSV has been directly involved
For pharmacodynamics PD Eleveld includes processed electroencephalogram EEG readings but only by nominal BIS index
The use of BIS as a unique marker of propofol hypnosis shows multiple limitations as it results from a computer algorithmic application which can be influenced by drugs inter-individual variability among others
Therefore to determine the effect there are nowadays more accurate tools such as spectrogram processing and determination of alpha power by spectral density PDS
This project aims to re-evaluate the modelling of the temporal behaviour of the effect in the BIS index using the reference of the Eleveld kinetic model associated to a spectrogram that allows the evaluation of the alpha and delta band dynamics as a predictor of the propofol effect
In our study we intend to replace the BIS value by the alpha and delta power progress in decibels dB and eventually build a pharmacodynamic PD model with a marker more associated to the specific cortical electrical phenomenon
This model called Universal includes data from all studies conducted with plasma levels in the world where the principal investigator PSV has been directly involved
For pharmacodynamics PD Eleveld includes processed electroencephalogram EEG readings but only by nominal BIS index
The use of BIS as a unique marker of propofol hypnosis shows multiple limitations as it results from a computer algorithmic application which can be influenced by drugs inter-individual variability among others
Therefore to determine the effect there are nowadays more accurate tools such as spectrogram processing and determination of alpha power by spectral density PDS
This project aims to re-evaluate the modelling of the temporal behaviour of the effect in the BIS index using the reference of the Eleveld kinetic model associated to a spectrogram that allows the evaluation of the alpha and delta band dynamics as a predictor of the propofol effect
In our study we intend to replace the BIS value by the alpha and delta power progress in decibels dB and eventually build a pharmacodynamic PD model with a marker more associated to the specific cortical electrical phenomenon
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None