Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers|
- 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.
- Transaminases [ Time Frame: February 2011 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: sevoflurane
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
Active Comparator: Propofol
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000337
|Aretaieio Hospital, University of Athens|
|Athens, Attiki, Greece, 11528|