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Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier:
NCT01000337
First received: October 22, 2009
Last updated: August 12, 2012
Last verified: August 2012

October 22, 2009
August 12, 2012
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 ] [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01000337 on ClinicalTrials.gov Archive Site
Transaminases [ Time Frame: February 2011 ] [ Designated as safety issue: Yes ]
Transaminases [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Liver Dysfunction
  • Drug: Sevoflurane
    Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
  • Drug: Propofol
    Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
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
Female
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01000337
Σ-74/07-07-2009
No
Argyro Fassoulaki, University of Athens
University of Athens
Not Provided
Not Provided
University of Athens
August 2012

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