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

This study has been terminated.
(lack of recrutment)
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: May 21, 2007
Last updated: September 22, 2016
Last verified: September 2016
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

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 ]

Enrollment: 5
Study Start Date: May 2007
Study Completion Date: September 2009
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00477347

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
Principal Investigator: Marc Fischler, MD
  More Information

Responsible Party: Hopital Foch Identifier: NCT00477347     History of Changes
Other Study ID Numbers: 2006/37
Study First Received: May 21, 2007
Last Updated: September 22, 2016

Keywords provided by Hopital Foch:
Liver Transplantation
Anesthesia, general

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 19, 2017