Closed-Loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation (Drone-TH)

This study has been withdrawn prior to enrollment.

(lack of recrutment)

Sponsor:

Information provided by:

Hopital Foch

ClinicalTrials.gov Identifier:

NCT00477347

First received: May 21, 2007

Last updated: March 12, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 21, 2007

Last Updated Date

March 12, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

consumption of propofol during anesthesia maintenance [ Time Frame: during anesthesia maintenance ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

consumption of propofol during anesthesia maintenance [ Time Frame: during anesthesia maintenance ]

Change History

Complete list of historical versions of study NCT00477347 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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. [ Time Frame: during anesthesia maintenance ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-Loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Liver Transplantation

Intervention ^ICMJE

Device: Closed loop administration
intraoperative closed loop administration of propofol and remifentanil

Other Name: closed-loop
Device: Manual administration
intraoperative manual administration of propofol and remifentanil

Other Name: target controlled anesthesia

Study Arm (s)

Active Comparator: 1
Manual administration

Intervention: Device: Manual administration
Experimental: 2
Closed-loop administration

Intervention: Device: Closed loop administration

Publications *

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.
Liu N, Hamada S, Chazot T, Landais A, Fischler M. Propofol and Remifentanil Guided Solely by the Bispectral Index: Closed-Loop Versus Manual Control. ASA 2006, A854

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

liver transplantation

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00477347

Other Study ID Numbers ^ICMJE

2006/37

Has Data Monitoring Committee

Responsible Party

Marc Fischler, Hopital Foch

Study Sponsor ^ICMJE

Hopital Foch

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marc Fischler, MD

Information Provided By

Hopital Foch

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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