HepatectomyPhase 3NCT00219856
Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy
A Phase 3 study testing Propofol, Penthotal and Desflurane in people with Hepatectomy, run by Rennes University Hospital at 1 site in France.
Trial summary
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Propofol, Penthotal and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2004to Mar 2006
- Phase
- Phase 3
- 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 over 18
- Need for partial hepatic resection requiring heptic clamping
- Resection of 4 liver segments or less
- In case of cirrhosis, child A
- Written informed consent
- Non-inclusion Criteria:
Show all 14Show fewer
- Hemochromatosis
- chemotherapy in the previous week before inclusion
- Thrombosis of the portal vein or the hepatic artery
- Absence of contraception among fertil woman
- Concomitant treatment that could have potential interaction with propofol
- Concomitant treatment known to have antioxidant properties
- Inclusion in another study protocol using a medication incompatible with the present study
- Patient in which the follow up seems impossible
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Surgical Intensive Care Unit - Rennes University Hospital
Rennes, 35033
About this study
Official title: Prospective, Randomized, Simple Blind Study Comparing the Effects of an Anaesthesia With Propofol to an Anaesthesia With Desflurane on Oxydative Stress and Liver Function Recovery After Hepatectomy
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.
The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.
Read the detailed description
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic hilum during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to ischemic-reperfusion injury, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.
The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic hilum clamping.
The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.
The evolution over time of other markers of oxidative stress will be studied (glutathione, myeloperoxidase, nitric oxide), as well as functional and biological markers of liver regeneration.
- Conditions
- Hepatectomy
- Being tested
- Propofol, Penthotal, Desflurane
- Keywords
- Propofol, Hepatectomy, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
- Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml
- Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml
PenthotalDrug
Intravenous penthotal at the dose of 3 to 5 mg/kg
DesfluraneDrug
Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Anesthesic induction and maintenance with intravenous propofol. Receives: Drug: Propofol |
| 2 | Active comparator | Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane. Receives: Drug: Penthotal; Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma MDA levels
Measured: 30 minutes after the end of hepatic clamping
Secondary outcomes (5)
Kinetics of post surgical biological hepatic function recovery
- Gamma gluatamyltransferase
- ASAT
- ALAT
- Factor V
- AlfagluthationeS-transferase
Measured: Days 1, 2, 5, 10
Kinetics of post surgical hepatic function recovery
Monoethylglycinexylidide (MEGX) test
Measured: Day 2
Other biological markers of oxidative stress
- Glutathione
- Myeloperoxidase
- Nitric oxide
Measured: Days 1 and 2
Hemodynamics during and after surgery
- Mean arterial pressure
- Heart rate
- Diuresis
Measured: Days 1 and 2
Surgery related complications
- Liver insufficiency
- Hepato renal syndrome
- Local infections
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- David Aguillon, MD, Principal investigator, Rennes University HospitalYannick Malledant, MD, Study director, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219856
- Sponsor's protocol ID
- AFSSAPS 040366
- Other IDs
- PHRC/03-02, CIC0203/026
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Simple Blind Study Comparing the Effects of an Anaesthesia With Propofol to an Anaesthesia With Desflurane on Oxydative Stress and Liver Function Recovery After Hepatectomy
- ClinicalTrials.gov ID
- NCT00219856
- Acronym / sponsor ID
- AFSSAPS 040366
- Conditions
- Hepatectomy
- Keywords
- Propofol, Hepatectomy, Oxidative stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Aug 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.
The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.
Detailed description
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic hilum during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to ischemic-reperfusion injury, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.
The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic hilum clamping.
The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.
The evolution over time of other markers of oxidative stress will be studied (glutathione, myeloperoxidase, nitric oxide), as well as functional and biological markers of liver regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PropofolAnesthesic induction and maintenance with intravenous propofol. |
| 2 | Active comparator | Drug: Penthotal, Drug: DesfluraneAnesthesic induction with intravenous penthotal and maintenance with inhaled desflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients over 18
- Need for partial hepatic resection requiring heptic clamping
- Resection of 4 liver segments or less
- In case of cirrhosis, child A
- Written informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Propofol* Induction : intravenous propofol aiming a concentration of 4 to 8 µg/ml * Maintenance : intravenous propofol aiming a concentration of 3 to 6 µg/ml | Drug | 1 |
| PenthotalIntravenous penthotal at the dose of 3 to 5 mg/kg | Drug | 2 |
| DesfluraneInhaled desflurane aiming an alveolar concentration of 4 to 6 per cent. | Drug | 2 |
Primary outcome
Plasma MDA levels
Time frame: 30 minutes after the end of hepatic clamping
5 secondary outcomes
Kinetics of post surgical biological hepatic function recovery
Time frame: Days 1, 2, 5, 10
Kinetics of post surgical hepatic function recovery
Time frame: Day 2
Other biological markers of oxidative stress
Time frame: Days 1 and 2
Hemodynamics during and after surgery
Time frame: Days 1 and 2
Surgery related complications
Time frame: 10 days
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 26 Jun 2012.
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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.
David Aguillon, MD principal investigator
Rennes University Hospital
Yannick Malledant, MD study director
Rennes University Hospital
Bruno Laviolle, MD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol, Penthotal and Desflurane in people with Hepatectomy, run by Rennes University Hospital 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 14 inclusion and 0 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 26 Jun 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Plasma MDA levels (time frame: 30 minutes after the end of hepatic clamping). 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 26 Jun 2012.