Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

NCT01000337 | Completed Results

• 1 other identifier: Σ-74/07-07-2009
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Dysfunction

Keywords

Liver Apoptosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Transaminases

  February 2011

Study Arms (2)

sevoflurane

ACTIVE COMPARATOR

Volatile anesthetic

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

Intravenous anesthetic

Drug: Propofol

Interventions

Sevoflurane DRUG

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

Also known as: Sevorane, 2802252901023,

sevoflurane

Propofol DRUG

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

Also known as: Lipuro, 2802467102017

Propofol

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

The study was accomplished with no problems leading to data questioning.

Results Point of Contact

• Title: Argyro Fassoulaki
• Organization: Aretaieio Hospital, University of Athens

fassoula@aretaieio.uoa.gr

+30210 7286334

Study Officials

• Argyro Fassoulaki, MD,PhD,DEAA

  Chairman Department of Anesthesiology, Aretaieio Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DEAA

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 19, 2017
• Results First Posted: September 11, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)