Back to resultsHyperoxic Oxidative Stress During Abdominal Surgery
Primary Purpose
Response to Hyperoxia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fraction of inspired oxygen 40%
Fraction of inspired oxygen 80%
Sponsored by
About this trial
This is an interventional prevention trial for Response to Hyperoxia
Eligibility 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
Sites / Locations
- Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
40% oxygen
80% oxygen
Arm Description
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.
Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery.
Outcomes
Primary Outcome Measures
oxidant and antioxidant response
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
Hemodynamics
The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01793454
Brief Title
Hyperoxic Oxidative Stress During Abdominal Surgery
Official Title
Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Response to Hyperoxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40% oxygen
Arm Type
Active Comparator
Arm Description
Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.
Arm Title
80% oxygen
Arm Type
Active Comparator
Arm Description
Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery.
Intervention Type
Other
Intervention Name(s)
Fraction of inspired oxygen 40%
Intervention Type
Other
Intervention Name(s)
Fraction of inspired oxygen 80%
Primary Outcome Measure Information:
Title
oxidant and antioxidant response
Description
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
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Hemodynamics
Description
The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yalim Dikmen, Prof.
Organizational Affiliation
Cerrahpasa Medical Faculty Chairman of Intensive Care Department
Official's Role
Study Director
Facility Information:
Facility Name
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34400
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
15055896
Citation
Koksal GM, Sayilgan C, Aydin S, Uzun H, Oz H. The effects of sevoflurane and desflurane on lipid peroxidation during laparoscopic cholecystectomy. Eur J Anaesthesiol. 2004 Mar;21(3):217-20. doi: 10.1017/s0265021504003102.
Results Reference
background
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Hyperoxic Oxidative Stress During Abdominal Surgery
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