Liver TransplantationPhase 4Drone-THNCT00477347
Closed-loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation
A Phase 4 study testing Closed loop administration and Manual administration in people with Liver Transplantation, run by Hopital Foch at 2 sites in France.
Trial summary
To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Closed loop administration and Manual administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesFrance
- Study dates
- May 2007to Sep 2009
- Phase
- Phase 4
- 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
- liver transplantation
Who cannot join
- pregnant women
- allergy to propofol or remifentanil,
- neurological or muscular disorder,
- liver encephalopathy,
- patients taking psychotropic agents
Trial locations and contacts
2 sites in 1 country.
France2 sites
Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, 92110
Dept of Anesthesia and Intensive Care, Hôpital H. Mondor
Créteil, 94000
About this study
Official title: Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation
To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation
Read the detailed description
The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We hypothesized that BIS can also indicate the adequacy of analgesia. Therefore we built a combined closed-loop anesthesia system using BIS as control variable and two proportional-differential control algorithms, a propofol and a remifentanil target-controlled infusion system. The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective, randomized study.
Elimination of anesthetic agents, propofol in particular, is strongly reduced during liver transplantation. Closed-loop anesthesia could provide adequacy for requirements in respect to the various phases of transplantation. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist, using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups the goal is to maintain BIS between 40 and 60, the range recommended by the manufacturer during anesthesia. We expect the combined closed-loop anesthesia system group to do better: i.e. diminished consumption of propofol (primary outcome measure).
- Conditions
- Liver Transplantation
- Being tested
- Closed loop administration, Manual administration
- Keywords
- Liver Transplantation, Anesthesia, general, Closed-loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop administrationDevice
Also called closed-loop
intraoperative closed loop administration of propofol and remifentanil
Manual administrationDevice
Also called target controlled anesthesia
intraoperative manual administration of propofol and remifentanil
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Manual administration Receives: Device: Manual administration |
| 2 | Experimental | Closed-loop administration Receives: Device: Closed loop administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of propofol during anesthesia maintenance
Measured: 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.
Measured: during anesthesia maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: lack of recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477347
- Sponsor's protocol ID
- 2006/37
- Acronym
- Drone-TH
- Status last verified
- Sep 2016
- First submitted
- 21 May 2007
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16571963
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation
- ClinicalTrials.gov ID
- NCT00477347
- Acronym / sponsor ID
- Drone-TH / 2006/37
- Conditions
- Liver Transplantation
- Keywords
- Liver Transplantation, Anesthesia, general, Closed-loop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recrutment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 May 2007 (estimated)
- 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.
To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation
Detailed description
The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We hypothesized that BIS can also indicate the adequacy of analgesia. Therefore we built a combined closed-loop anesthesia system using BIS as control variable and two proportional-differential control algorithms, a propofol and a remifentanil target-controlled infusion system. The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective, randomized study.
Elimination of anesthetic agents, propofol in particular, is strongly reduced during liver transplantation. Closed-loop anesthesia could provide adequacy for requirements in respect to the various phases of transplantation. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist, using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups the goal is to maintain BIS between 40 and 60, the range recommended by the manufacturer during anesthesia. We expect the combined closed-loop anesthesia system group to do better: i.e. diminished consumption of propofol (primary outcome measure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Manual administrationManual administration |
| 2 | Experimental | Device: Closed loop administrationClosed-loop administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- liver transplantation
Key exclusion criteria (5 listed)
- pregnant women
- allergy to propofol or remifentanil,
- neurological or muscular disorder,
- liver encephalopathy,
- patients taking psychotropic agents
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 |
|---|---|---|
| Closed loop administrationAlso: closed-loopintraoperative closed loop administration of propofol and remifentanil | Device | 2 |
| Manual administrationAlso: target controlled anesthesiaintraoperative manual administration of propofol and remifentanil | Device | 1 |
Primary outcome
consumption of propofol during anesthesia maintenance
Time frame: during anesthesia maintenance
1 secondary outcome
- 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.
Time frame: during anesthesia maintenance
Results and safety
The study was stopped early (reason given: lack of recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Background: PubMed 16571963Liu 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.
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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, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Closed loop administration and Manual administration in people with Liver Transplantation, run by Hopital Foch at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recrutment). Results are not available in the source record.
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?
consumption of propofol during anesthesia maintenance (time frame: during anesthesia maintenance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477347, which also lists 1 linked publication.
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 23 Sep 2016.