NCT00477347

Closed-loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation

Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DEVICE	Closed loop administration	intraoperative closed loop administration of propofol and remifentanil
DEVICE	Manual administration	intraoperative manual administration of propofol and remifentanil

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-05-23
• Last updated: 2016-09-23

Locations

2 sites across 1 country: France