Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

Not Applicable

Completed

• Conditions: Liver Dysfunction
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT01000337
• Lead Sponsor: University of Athens

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Primary Completion: 2011-11
• Study Completion: 2012-04
• Results First Submitted: 2012-05-07
• Results First Submitted QC: 2012-08-12
• Results First Posted: 2012-09-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Intravenous anesthetic
sevoflurane	Sevoflurane	Volatile anesthetic

Primary Outcome Measures

Name	Time	Method
Changes in the M30 and M65 Markers Related to the Anesthesia Type	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 Outcome Measures

Name	Time	Method
Transaminases	February 2011

Trial Locations

Locations (1)

Aretaieio Hospital, University of Athens; 🇬🇷 Athens, Attiki, Greece