A Phase 4 interventional study of Closed loop administration and Manual administration in Liver Transplantation, sponsored by Hopital Foch. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment
To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation
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).
Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Manual administration
Device: Manual administration
Closed-loop administration
Device: Closed loop administration
intraoperative closed loop administration of propofol and remifentanil
Also known as: closed-loop
intraoperative manual administration of propofol and remifentanil
Also known as: target controlled anesthesia
consumption of propofol during anesthesia maintenance
Time frame: during anesthesia maintenance
- 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
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hopital Foch