Closed-loop Anesthesia, Using Bispectral Index as the Con... | NCT00477347

Studies
Closed-loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation

NCT00477347

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Sep 23, 2016Estimated

Enrollment

5Actual

Phase

Phase 4

Conditions

Liver Transplantation

Interventions

Closed loop administration
Manual administration

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recrutment

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

May 21, 2007

First Submission Date that Met QC Criteria

May 22, 2007

First Posted Date

May 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2016

Last Update Posted Date

Sep 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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: i.e. diminished consumption of propofol (primary outcome measure).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Manual administration	Device: Manual administration
2	Experimental	Closed-loop administration	Device: Closed loop administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closed loop administration	Device	intraoperative closed loop administration of propofol and remifentanil	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
consumption of propofol during anesthesia maintenance		during anesthesia maintenance

Secondary Outcomes

Measure	Description	Time Frame
- consumption of remifentanil - target modifications - hemodynamic events - volume loading and transfusion - extubation time, explicit memorization - time passed at BIS between 40 and 60 - MDAPE, wobble - global score - dysfunction of each system.		during anesthesia maintenance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver transplantation

Exclusion Criteria:

pregnant women
allergy to propofol or remifentanil,
neurological or muscular disorder,
liver encephalopathy,
patients taking psychotropic agents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesia and Intensive Care, Hôpital Beaujon		Clichy		92110	France
Dept of Anesthesia and Intensive Care, Hôpital H. Mondor

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16571963	Background	Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.