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Closed-loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation (Drone-TH)

H

Hopital Foch

Status and phase

Terminated
Phase 4

Conditions

Liver Transplantation

Treatments

Device: Closed loop administration
Device: Manual administration

Study type

Interventional

Funder types

Other

Identifiers

NCT00477347
2006/37

Details and patient eligibility

About

To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation

Full 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).

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • liver transplantation

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

5 participants in 2 patient groups

1
Active Comparator group
Description:
Manual administration
Treatment:
Device: Manual administration
2
Experimental group
Description:
Closed-loop administration
Treatment:
Device: Closed loop administration

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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