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Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000337
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : September 11, 2012
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

October 22, 2009
October 23, 2009
May 7, 2012
September 11, 2012
May 19, 2017
October 2009
November 2011   (Final data collection date for primary outcome measure)
Changes in the M30 and M65 Markers Related to the Anesthesia Type [ Time Frame: preoperatively, end of surgery, 24 and 48 hours postoperatively ]
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.
Changes in the M30 and M60 markers related to the anesthesia type
Complete list of historical versions of study NCT01000337 on Archive Site
Transaminases [ Time Frame: February 2011 ]
Not Provided
Not Provided
Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
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.

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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Liver Dysfunction
  • Drug: Sevoflurane
    Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
    Other Name: Sevorane, 2802252901023,
  • Drug: Propofol
    Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
    Other Name: Lipuro, 2802467102017
  • Active Comparator: sevoflurane
    Volatile anesthetic
    Intervention: Drug: Sevoflurane
  • Active Comparator: Propofol
    Intravenous anesthetic
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2012
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
30 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
Argyro Fassoulaki, University of Athens
University of Athens
Not Provided
Study Chair: Argyro Fassoulaki, MD,PhD,DEAA Chairman Department of Anesthesiology, Aretaieio Hospital
University of Athens
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP