Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392158
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2006-10-24
Brief Title:
Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral Comparison Between Manual Perfusion and Automated Perfusion
Status:
COMPLETED
Status Verified Date:
2016-09
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:
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia
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 a proportional-integral-differential control algorithm and a propofol target-controlled infusion system as the control actuator Recent studies have shown that such system is able to provide clinically adequate anesthesia We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system 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 In preparation for a large multi-center control trial we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system 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 anesthesia 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