Hyperoxic Oxidative Stress During Abdominal Surgery
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ClinicalTrials.gov Identifier: NCT01793454 |
Recruitment Status :
Completed
First Posted : February 15, 2013
Last Update Posted : April 9, 2015
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Condition or disease | Intervention/treatment | Phase |
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Response to Hyperoxia | Other: Fraction of inspired oxygen 40% Other: Fraction of inspired oxygen 80% | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 40% oxygen
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.
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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% |
- 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
- Hemodynamics [ Time Frame: 4 hours ]The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.

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

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
Turkey | |
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department | |
Istanbul, Fatih, Turkey, 34400 |
Study Director: | Yalim Dikmen, Prof. | Cerrahpasa Medical Faculty Chairman of Intensive Care Department |
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 |
Hyperoxia Signs and Symptoms, Respiratory |