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Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study

NCT ID: NCT03357900

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-18

Study Completion Date

2012-02-09

Brief Summary

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Automated titration of propofol and remifentanil guided by the bispectral index (BIS) has been used for numerous surgical procedures. Orthotopic liver transplantation (OLT) uniquely combines major volaemic changes, an anhepatic phase, and ischaemia-reperfusion syndrome. We assessed the behaviour of this automated controller during OLT

Detailed Description

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Conditions

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Anesthesia Liver Transplant

Keywords

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Consciousness Monitor Clinical Pharmacology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orthotopic liver transplantation

Group Type EXPERIMENTAL

Automated titration of propofol and remifentanil

Intervention Type DEVICE

Calculation of Consumption of propofol and remifentanil

Interventions

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Automated titration of propofol and remifentanil

Calculation of Consumption of propofol and remifentanil

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients scheduled for OLT

Exclusion Criteria

age younger than 18 years, pregnancy, allergy or hypersensitivity to propofol or remifentanil, a medical history of psychiatric illness, and supraspinal neurological disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00363-54

Identifier Type: OTHER

Identifier Source: secondary_id

2009/09

Identifier Type: -

Identifier Source: org_study_id