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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC/03-02 | Other Identifier | Rennes University Hospital | |
| CIC0203/026 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Anesthesic induction and maintenance with intravenous propofol. |
|
| 2 | Active Comparator | Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma MDA levels | 30 minutes after the end of hepatic clamping |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics of post surgical biological hepatic function recovery |
| Days 1, 2, 5, 10 |
| Kinetics of post surgical hepatic function recovery |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Aguillon, MD | Rennes University Hospital | Principal Investigator |
| Yannick Malledant, MD | Rennes University Hospital | Study Director |
| Bruno Laviolle, MD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Intensive Care Unit - Rennes University Hospital | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Penthotal | Drug | Intravenous penthotal at the dose of 3 to 5 mg/kg |
|
| Desflurane | Drug | Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent. |
|
Monoethylglycinexylidide (MEGX) test
| Day 2 |
| Other biological markers of oxidative stress |
| Days 1 and 2 |
| Hemodynamics during and after surgery |
| Days 1 and 2 |
| Surgery related complications |
| 10 days |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |