The Comparison of Oxidative Stress Between Inhalation Anesthetics

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00965445
First received: August 23, 2009
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to investigate the effect of different anesthetics on isoprostanes.


Condition
Oxidative Stress
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Comparison of Oxidative Stress Between Inhalation Anesthetics

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • isoprostanes isomer as marker of oxidative stress [ Time Frame: one day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

thirty milliliters of urine was collected from urine bag of patients at the following times: baseline before anesthesia, 30 minutes before cardiopulmonary bypass, during cardiopulmonary bypass, after the end of cardiopulmonary bypass.


Enrollment: 60
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac surgery with CPB

Detailed Description:

Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue.

Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients receiving cardiac valve surgery in Taipei Change Gung Memorial Hospital will be invited to participate this study

Criteria

Inclusion Criteria:

  • patients receiving cardiac valve surgery in ASA II-III physical status

Exclusion Criteria:

  • trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965445

Locations
Taiwan
Dept. of Anesthesiology, Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yun-Hui Teng, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00965445     History of Changes
Other Study ID Numbers: CGMH-IRB-96-0019B, CGMH-IRB-96-0019B
Study First Received: August 23, 2009
Last Updated: August 24, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
isoprostanes
mass spectrometry

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General

ClinicalTrials.gov processed this record on August 21, 2014