Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584097
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
COMparative Performance of General Purpose Models
Sponsor:
None
Organization:
None
Study Overview
Official Title:
COMparative Performance of General Purpose Models for Propofol and REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance
Detailed Description:
Despite the widespread adoption of Target Controlled Infusion TCI models in modern clinical anesthesia practice much less attention has been paid in the literature to their potential applications in the Intensive Care Unit ICU setting Few studies have been published so far to evaluate the performance of TCI pumps for sedatives and other drugs eg antibiotics in Intensive Care Further data is needed regarding the use of TCI for the long-term infusion of these drugs in the ICU after surgery and the quantitative relationship between generalized pharmacokineticpharmacodynamic models for propofol and remifentanil the Eleveld models has yet to be evaluated in this specific population This study is an observational study with the aim of clarifying the predictive performance of the TCI models for the administration of propofol and remifentanil in a cohort of intensive care patients admitted after neurosurgery and compare it to the intraoperative performance which can be taken as benchmark
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None