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Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

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ClinicalTrials.gov Identifier: NCT01000337
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : September 11, 2012
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Dysfunction Drug: Sevoflurane Drug: Propofol Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
Study Start Date : October 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: sevoflurane
Volatile anesthetic
 Drug: Sevoflurane
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
Other Name: Sevorane, 2802252901023,
Active Comparator: Propofol
Intravenous anesthetic
 Drug: Propofol
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
Other Name: Lipuro, 2802467102017


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Transaminases [ Time Frame: February 2011 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000337


Locations
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Greece
Aretaieio Hospital, University of Athens
Athens, Attiki, Greece, 11528
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: Argyro Fassoulaki, MD,PhD,DEAA Chairman Department of Anesthesiology, Aretaieio Hospital
More Information
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Responsible Party: Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
ClinicalTrials.gov Identifier: NCT01000337    
Other Study ID Numbers: Σ-74/07-07-2009
First Posted: October 23, 2009    Key Record Dates
Results First Posted: September 11, 2012
Last Update Posted: May 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Argyro Fassoulaki, University of Athens:
Liver Apoptosis
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation