AnesthesiaTHConcentrNCT03357900
Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study
A study testing Automated titration of propofol and remifentanil in people with Anesthesia and Liver Transplant, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Liver Transplant
- What is being tested?
- Automated titration of propofol and remifentanil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2010to 9 Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for OLT
Who cannot join
- age younger than 18 years, pregnancy, allergy or hypersensitivity to propofol or remifentanil, a medical history of psychiatric illness, and supraspinal neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Anesthesia, Liver Transplant
- Being tested
- Automated titration of propofol and remifentanil
- Keywords
- Consciousness Monitor, Clinical Pharmacology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated titration of propofol and remifentanilDevice
Calculation of Consumption of propofol and remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Orthotopic liver transplantation | Experimental | Not described Receives: Device: Automated titration of propofol and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time spent in the BIS interval [40-60]
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start18 Aug 2010
- Primary completion9 Feb 2012
- Study completion9 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357900
- Sponsor's protocol ID
- 2009/09
- Other IDs
- 2009-A00363-54
- Acronym
- THConcentr
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study
- ClinicalTrials.gov ID
- NCT03357900
- Acronym / sponsor ID
- THConcentr / 2009/09
- Conditions
- Anesthesia, Liver Transplant
- Keywords
- Consciousness Monitor, Clinical Pharmacology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 18 Aug 2010 (actual)
- Primary completion
- 9 Feb 2012 (actual)
- Study completion
- 9 Feb 2012 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthotopic liver transplantation | Experimental | Device: Automated titration of propofol and remifentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for OLT
Key exclusion criteria (1 listed)
- age younger than 18 years, pregnancy, allergy or hypersensitivity to propofol or remifentanil, a medical history of psychiatric illness, and supraspinal neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated titration of propofol and remifentanilCalculation of Consumption of propofol and remifentanil | Device | Orthotopic liver transplantation |
Primary outcome
percentage of time spent in the BIS interval [40-60]
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Fischler principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated titration of propofol and remifentanil in people with Anesthesia and Liver Transplant, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of time spent in the BIS interval [40-60] (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.