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Hyperoxic Oxidative Stress During Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793454
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Guniz M.Koksal, Istanbul University

Study Description
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Brief Summary:
Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality, preanesthetic and postanesthetic expiration tidal volumes.

Condition or disease Intervention/treatment Phase
Response to Hyperoxia Other: Fraction of inspired oxygen 40% Other: Fraction of inspired oxygen 80% Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 40% oxygen
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.
 Other: Fraction of inspired oxygen 40%
Active Comparator: 80% oxygen
Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery.
 Other: Fraction of inspired oxygen 80%


Outcome Measures
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Primary Outcome Measures :
  1. oxidant and antioxidant response [ Time Frame: 4 hours ]
    As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in plasma and bronchoalveolar lavage after intubation and prior to extubation will be evaluated


Secondary Outcome Measures :
  1. Hemodynamics [ Time Frame: 4 hours ]
    The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing abdominal surgery, between 20-60 years old, with American Society of Anesthesiology score I or II

Exclusion Criteria:

  • Patients with Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, muscle-bone diseases, inflammatory bowel diseases and patients with malnutrition.

Patients will be recruited through general surgery service of our hospital

Contacts and Locations
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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): NCT01793454


Locations
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Turkey
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, Turkey, 34400
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Yalim Dikmen, Prof. Cerrahpasa Medical Faculty Chairman of Intensive Care Department
More Information
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Publications:

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Responsible Party: Guniz M.Koksal, Assoc.Prof., Istanbul University
ClinicalTrials.gov Identifier: NCT01793454    
Other Study ID Numbers: 36048
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms