Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
Primary Purpose
Liver Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by

About this trial
This is an interventional other trial for Liver Dysfunction focused on measuring Liver Apoptosis
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
Sites / Locations
- Aretaieio Hospital, University of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
sevoflurane
Propofol
Arm Description
Volatile anesthetic
Intravenous anesthetic
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Transaminases
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01000337
Brief Title
Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
Official Title
The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction
Keywords
Liver Apoptosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
Volatile anesthetic
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Intravenous anesthetic
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane, 2802252901023,
Intervention Description
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Lipuro, 2802467102017
Intervention Description
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
Primary Outcome Measure Information:
Title
Changes in the M30 and M65 Markers Related to the Anesthesia Type
Description
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.
Time Frame
preoperatively, end of surgery, 24 and 48 hours postoperatively
Secondary Outcome Measure Information:
Title
Transaminases
Time Frame
February 2011
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argyro Fassoulaki, MD,PhD,DEAA
Organizational Affiliation
Chairman Department of Anesthesiology, Aretaieio Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aretaieio Hospital, University of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
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