Closed-loop Anaesthesia for Liver Transplantation: a Pilo... | NCT03357900

Studies
Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study

NCT03357900

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Nov 30, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Anesthesia
Liver Transplant

Interventions

Automated titration of propofol and remifentanil

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00363-54	Other Identifier	ANSM

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2010Actual

Primary Completion Date

Feb 9, 2012Actual

Completion Date

Feb 9, 2012Actual

First Submitted Date

Nov 24, 2017

First Submission Date that Met QC Criteria

Nov 24, 2017

First Posted Date

Nov 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2017

Last Update Posted Date

Nov 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orthotopic liver transplantation	Experimental		Device: Automated titration of propofol and remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Automated titration of propofol and remifentanil	Device	Calculation of Consumption of propofol and remifentanil	Orthotopic liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of time spent in the BIS interval [40-60]		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler	Hopital Foch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Foch		Suresnes		92150	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided