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

Phase 4

Terminated

• Conditions: Liver Transplantation
• Interventions: Device: Closed loop administration; Device: Manual administration

• Registration Number: NCT00477347
• Lead Sponsor: Hopital Foch

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).

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-23
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• liver transplantation

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Exclusion Criteria

• pregnant women
• allergy to propofol or remifentanil,
• neurological or muscular disorder,
• liver encephalopathy,
• patients taking psychotropic agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Closed loop administration	Closed-loop administration
1	Manual administration	Manual administration

Primary Outcome Measures

Name	Time	Method
consumption of propofol during anesthesia maintenance	during anesthesia maintenance

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (2)

Dept of Anesthesia and Intensive Care, Hôpital Beaujon; 🇫🇷 Clichy, France

Dept of Anesthesia and Intensive Care, Hôpital H. Mondor; 🇫🇷 Créteil, France