Liver Transplantation
Conditions
Keywords
Liver Transplantation, Anesthesia, general, Closed-loop
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).
Interventions
DEVICEClosed loop administration
intraoperative closed loop administration of propofol and remifentanil
DEVICEManual administration
intraoperative manual administration of propofol and remifentanil
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| consumption of propofol during anesthesia maintenance | during anesthesia maintenance |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed