Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Rennes, Francia, 35033
- Surgical Intensive Care Unit - Rennes University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1
Anesthesic induction and maintenance with intravenous propofol.
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Comparador activo: 2
Anesthesic induction with intravenous penthotal and maintenance with inhaled desflurane.
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Intravenous penthotal at the dose of 3 to 5 mg/kg
Inhaled desflurane aiming an alveolar concentration of 4 to 6 per cent.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Plasma MDA levels
Periodo de tiempo: 30 minutes after the end of hepatic clamping
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30 minutes after the end of hepatic clamping
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kinetics of post surgical biological hepatic function recovery
Periodo de tiempo: Days 1, 2, 5, 10
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Days 1, 2, 5, 10
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Kinetics of post surgical hepatic function recovery
Periodo de tiempo: Day 2
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Monoethylglycinexylidide (MEGX) test
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Day 2
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Other biological markers of oxidative stress
Periodo de tiempo: Days 1 and 2
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Days 1 and 2
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Hemodynamics during and after surgery
Periodo de tiempo: Days 1 and 2
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Days 1 and 2
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Surgery related complications
Periodo de tiempo: 10 days
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10 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Yannick Malledant, MD, Rennes University Hospital
- Silla de estudio: Bruno Laviolle, MD, Rennes University Hospital
- Investigador principal: David Aguillon, MD, Rennes University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AFSSAPS 040366
- PHRC/03-02 (Otro identificador: Rennes University Hospital)
- CIC0203/026
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