THConcentr: Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study
Sponsor
Hopital Foch (Other)
Overall Status
Completed
CT.gov ID
NCT03357900
Collaborator
(none)
12
1
1
17.7
0.7
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study
Actual Study Start Date
:
Aug 18, 2010
Actual Primary Completion Date
:
Feb 9, 2012
Actual Study Completion Date
:
Feb 9, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Orthotopic liver transplantation
|
Device: Automated titration of propofol and remifentanil
Calculation of Consumption of propofol and remifentanil
|
Outcome Measures
Primary Outcome Measures
- percentage of time spent in the BIS interval [40-60] [1 day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Foch | Suresnes | France | 92150 |
Sponsors and Collaborators
- Hopital Foch
Investigators
- Principal Investigator: Marc Fischler, Hopital Foch
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT03357900
Other Study ID Numbers:
- 2009/09
- 2009-A00363-54
First Posted:
Nov 30, 2017
Last Update Posted:
Nov 30, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hopital Foch
Additional relevant MeSH terms: