NCT00477347

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2007

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

May 21, 2007

Last Update Submit

September 22, 2016

Conditions

Liver Transplantation

Keywords

Liver TransplantationAnesthesia, generalClosed-loop

Outcome Measures

Primary Outcomes (1)

  • consumption of propofol during anesthesia maintenance

    during anesthesia maintenance

Secondary Outcomes (1)

  • - 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

Study Arms (2)

1

ACTIVE COMPARATOR

Manual administration

Device: Manual administration

2

EXPERIMENTAL

Closed-loop administration

Device: Closed loop administration

Interventions

Closed loop administrationDEVICE

intraoperative closed loop administration of propofol and remifentanil

Also known as: closed-loop
2
Manual administrationDEVICE

intraoperative manual administration of propofol and remifentanil

Also known as: target controlled anesthesia
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Anesthesia and Intensive Care, Hôpital Beaujon

Clichy, 92110, France

Location

Dept of Anesthesia and Intensive Care, Hôpital H. Mondor

Créteil, 94000, France

Location

Related Publications (1)

  • 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.

    PMID: 16571963BACKGROUND

Study Officials

  • Marc Fischler, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 23, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(2)