The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Changes in the M30 and M65 Markers Related to the Anesthesia Type
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
sevoflurane
Volatile anesthetic
Intervention: Sevoflurane (Drug)
Propofol
Intravenous anesthetic
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Transaminases(February 2011)
Investigators
Argyro Fassoulaki
MD, PhD, DEAA
University of Athens