Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

Liver Dysfunction Clinical Trial

Official title:

The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000337
• Other study ID #: S-74/07-07-2009
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: August 12, 2012
• Start date: October 2009
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Liver Dysfunction

Intervention

Drug:
• Sevoflurane
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
• Propofol
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h

Locations

Country	Name	City	State
Greece	Aretaieio Hospital, University of Athens	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the M30 and M65 Markers Related to the Anesthesia Type	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.	preoperatively, end of surgery, 24 and 48 hours postoperatively	Yes
Secondary	Transaminases		February 2011	Yes