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

NCT ID: NCT00477347

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-09-30

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).

Conditions

Liver Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Manual administration

Group Type: ACTIVE_COMPARATOR

Manual administration

Intervention Type: DEVICE

intraoperative manual administration of propofol and remifentanil

2

Closed-loop administration

Group Type: EXPERIMENTAL

Closed loop administration

Intervention Type: DEVICE

intraoperative closed loop administration of propofol and remifentanil

Interventions

Closed loop administration

intraoperative closed loop administration of propofol and remifentanil

Intervention Type: DEVICE

Manual administration

intraoperative manual administration of propofol and remifentanil

Intervention Type: DEVICE

Other Intervention Names

closed-loop; target controlled anesthesia

Eligibility Criteria

Inclusion Criteria

• liver transplantation

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Fischler, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Dept of Anesthesia and Intensive Care, Hôpital Beaujon

Clichy, , France

Dept of Anesthesia and Intensive Care, Hôpital H. Mondor

Créteil, , France

Countries

France

References

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

Reference Type: BACKGROUND

PMID: 16571963 (View on PubMed)

Other Identifiers

2006/37

Identifier Type: -

Identifier Source: org_study_id