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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 22, 2009
Last Updated Date	August 12, 2012
Start Date ^ICMJE	October 2009
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 ] [ 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.
Original Primary Outcome Measures ^ICMJE (submitted: October 22, 2009)	Changes in the M30 and M60 markers related to the anesthesia type [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01000337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 22, 2011)	Transaminases [ Time Frame: February 2011 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 22, 2009)	Transaminases [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Condition ^ICMJE	Liver Dysfunction
Intervention ^ICMJE	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
Study Arm (s)	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
Enrollment ^ICMJE	67
Completion Date	April 2012
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
Gender	Female
Ages	30 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01000337
Other Study ID Numbers ^ICMJE	Σ-74/07-07-2009
Has Data Monitoring Committee	No
Responsible Party	Argyro Fassoulaki, University of Athens
Study Sponsor ^ICMJE	University of Athens
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Athens
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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