Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

Study Overview
=================
Brief Summary
-----------------
Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's hypothesis is that intravenous or inhalation anesthesia does not impair liver function as assessed by more elegant tests like markers indicating liver apoptosis. In the present randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be determined.

Detailed Description
-----------------
Female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol anesthesia will be recruited for the study. The type of anesthesia will be determined in a random way using a computer generated table. All patients will be preoxygenated for 3 minutes before induction of anesthesia. Patients assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a primed anesthetic circle system and anesthesia will be maintained with sevoflurane. In the propofol group patients anaesthesia will be induced and maintained with propofol. Blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively. Blood samples will be centrifuged, stored at -80 degrees Celsius and analyzed for M30 and M60 values with radioimmunoassay technique. Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) levels will also be determined.

Official Title
-----------------
The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers

Conditions
-----------------
Liver Dysfunction

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer Exclusion Criteria: Drug intake which may affect liver function Severe cardiovascular or respiratory disease Hepatic or renal dysfunction Pregnancy Alcohol and drug abuse Body Mass Index (BMI) > 35

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sevoflurane<br>Volatile anesthetic | Drug: Sevoflurane<br>* Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.<br>* Other names: Sevorane, 2802252901023,;|
| Active Comparator: Propofol<br>Intravenous anesthetic | Drug: Propofol<br>* Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h<br>* Other names: Lipuro, 2802467102017;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the M30 and M65 Markers Related to the Anesthesia Type | Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively. | preoperatively, end of surgery, 24 and 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transaminases |  | February 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Apoptosis