Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

NCT ID: NCT01000337

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-04-30

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.

Conditions

Liver Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

sevoflurane

Volatile anesthetic

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.

Propofol

Intravenous anesthetic

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h

Interventions

Sevoflurane

Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.

Intervention Type: DRUG

Propofol

Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h

Intervention Type: DRUG

Other Intervention Names

Sevorane, 2802252901023,; Lipuro, 2802467102017

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Argyro Fassoulaki

MD, PhD, DEAA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Argyro Fassoulaki, MD,PhD,DEAA

Role: STUDY_CHAIR

Chairman Department of Anesthesiology, Aretaieio Hospital

Locations

Aretaieio Hospital, University of Athens

Athens, Attica, Greece

Countries

Greece

Other Identifiers

Σ-74/07-07-2009

Identifier Type: -

Identifier Source: org_study_id