Clinical trial NCT00477347: Closed-loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation
Official title: Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: Liver Transplantation
Anesthesia, general
Closed-loop
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2007-05-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: consumption of propofol during anesthesia maintenance
timeFrame: during anesthesia maintenance
Secondary outcomes:
measure: - 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.
timeFrame: during anesthesia maintenance
Other outcomes:
Locations:
city: Clichy
country: France
facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon
city: Créteil
country: France
facility: Dept of Anesthesia and Intensive Care, Hôpital H. Mondor
Study officials:
name: Marc Fischler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.