Hyperoxic Oxidative Stress During Abdominal Surgery

Response to Hyperoxia Clinical Trial

Official title:

Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793454
• Other study ID #: 36048
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: April 8, 2015
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Response to Hyperoxia

Intervention

Other:
• Fraction of inspired oxygen 40%

• Fraction of inspired oxygen 80%

Locations

Country	Name	City	State
Turkey	Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 hours	No
Secondary	Hemodynamics	The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.	4 hours	No