Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477347
Status:
TERMINATED
Last Update Posted:
2016-09-23
First Post:
2007-05-21
Brief Title:
Closed-loop Anesthesia Using Bispectral Index as the Control Variable During Liver Transplantation
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop Using Bispectral Index as the Control Variable During Liver Transplantation
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recrutment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Drone-TH
Brief Summary:
To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation
Detailed Description:
The Bispectral Index BIS is an electroencephalogram-derived measure of anesthetic depth We hypothesized that BIS can also indicate the adequacy of analgesia Therefore we built a combined closed-loop anesthesia system using BIS as control variable and two proportional-differential control algorithms a propofol and a remifentanil target-controlled infusion system The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective randomized study
Elimination of anesthetic agents propofol in particular is strongly reduced during liver transplantation Closed-loop anesthesia could provide adequacy for requirements in respect to the various phases of transplantation 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 range recommended by the manufacturer during anesthesia We expect the combined closed-loop anesthesia system group to do better ie diminished consumption of propofol primary outcome measure
Elimination of anesthetic agents propofol in particular is strongly reduced during liver transplantation Closed-loop anesthesia could provide adequacy for requirements in respect to the various phases of transplantation 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 range recommended by the manufacturer during anesthesia We expect the combined closed-loop anesthesia system group to do better ie diminished consumption of propofol primary outcome measure
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