Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393003
Status:
COMPLETED
Last Update Posted:
2009-08-31
First Post:
2006-10-24
Brief Title:
Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index Comparison Between Manual Perfusion and Automated Perfusion
Status:
COMPLETED
Status Verified Date:
2009-08
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:
None
Brief Summary:
This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period
Detailed Description:
The Bispectral Index BIS is an electroencephalogram-derived measure of anesthetic depth A closed-loop anesthesia system can be built using BIS as the control variable two proportional-integral-differential control algorithms a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period Two groups of patients are compared one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system In both groups the goal is to maintain BIS between 40 and 60 the recommended range during anesthesia by the manufacturer We expect the combined closed-loop system group to do similar or better
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