NCT01793454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

February 14, 2013

Last Update Submit

April 8, 2015

Conditions

Response to Hyperoxia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Hemodynamics

    4 hours

Study Arms (2)

40% oxygen

ACTIVE COMPARATOR

Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery.

Other: Fraction of inspired oxygen 40%

80% oxygen

ACTIVE COMPARATOR

Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery.

Other: Fraction of inspired oxygen 80%

Interventions

Fraction of inspired oxygen 40%OTHER
40% oxygen
Fraction of inspired oxygen 80%OTHER
80% oxygen

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department

Istanbul, Fatih, 34400, Turkey (Türkiye)

Location

Related 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. doi: 10.1017/s0265021504003102.

    PMID: 15055896BACKGROUND

Study Officials

  • Yalim Dikmen, Prof.

    Cerrahpasa Medical Faculty Chairman of Intensive Care Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

TU(1)