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This study has been withdrawn prior to enrollment.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
  Purpose

To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation


Condition Intervention Phase
Liver Transplantation
Device: Closed loop administration
Device: Manual administration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-Loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

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

Secondary Outcome Measures:
  • - 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 ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Manual administration
Device: Manual administration
intraoperative manual administration of propofol and remifentanil
Other Name: target controlled anesthesia
Experimental: 2
Closed-loop administration
Device: Closed loop administration
intraoperative closed loop administration of propofol and remifentanil
Other Name: closed-loop

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • liver transplantation

Exclusion Criteria:

  • pregnant women
  • allergy to propofol or remifentanil,
  • neurological or muscular disorder,
  • liver encephalopathy,
  • patients taking psychotropic agents
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00477347

Locations
France
Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, France, 92110
Dept of Anesthesia and Intensive Care, Hôpital H. Mondor
Créteil, France, 94000
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Marc Fischler, MD
  More Information

Publications:
Responsible Party: Marc Fischler, Hopital Foch
ClinicalTrials.gov Identifier: NCT00477347     History of Changes
Other Study ID Numbers: 2006/37
Study First Received: May 21, 2007
Last Updated: March 12, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
Liver Transplantation
Anesthesia, general
Closed-loop

Additional relevant MeSH terms:
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 16, 2014