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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.
 
ClinicalTrials.gov Identifier: NCT01000337
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : September 11, 2012
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 23, 2009
Results First Submitted Date  ICMJE May 7, 2012
Results First Posted Date  ICMJE September 11, 2012
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Changes in the M30 and M60 markers related to the anesthesia type
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2011)
Transaminases [ Time Frame: February 2011 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Transaminases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
Official Title  ICMJE The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Liver Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: sevoflurane
    Volatile anesthetic
    Intervention: Drug: Sevoflurane
  • Active Comparator: Propofol
    Intravenous anesthetic
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2012)
67
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000337
Other Study ID Numbers  ICMJE Σ-74/07-07-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Argyro Fassoulaki, University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Argyro Fassoulaki, MD,PhD,DEAA Chairman Department of Anesthesiology, Aretaieio Hospital
PRS Account University of Athens
Verification Date April 2017

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