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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

Tracking Information
First Submitted Date  ICMJE February 14, 2013
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date April 9, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2013)
superoxide dismutase (SOD) [ Time Frame: 4 hours ]
Superoxide dismutase (SOD)- (a response to oxidative stress) levels will be evaluated in plasma and bronchoalveolar lavage material taken after intubation and prior to extubation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
Hemodynamics [ Time Frame: 4 hours ]
The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2013)
Expiratory Tidal Volume [ Time Frame: 4 hours ]
Expiratory tidal volumes will be measured and compared both before anesthesia induction and 15 minutes after extubation with Wright Respirometer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperoxic Oxidative Stress During Abdominal Surgery
Official Title  ICMJE Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Response to Hyperoxia
Intervention  ICMJE
  • Other: Fraction of inspired oxygen 40%
  • Other: Fraction of inspired oxygen 80%
Study Arms  ICMJE
  • Active Comparator: 40% oxygen
    Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.
    Intervention: 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.
    Intervention: Other: Fraction of inspired oxygen 80%
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01793454
Other Study ID Numbers  ICMJE 36048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guniz M.Koksal, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yalim Dikmen, Prof. Cerrahpasa Medical Faculty Chairman of Intensive Care Department
PRS Account Istanbul University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP