Response to HyperoxiaNCT01793454
Hyperoxic Oxidative Stress During Abdominal Surgery
A study testing Fraction of inspired oxygen 40% and Fraction of inspired oxygen 80% in people with Response to Hyperoxia, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Response to Hyperoxia
- What is being tested?
- Fraction of inspired oxygen 40% and Fraction of inspired oxygen 80%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing abdominal surgery, between 20-60 years old, with American Society of Anesthesiology score I or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, 34400
About this study
Official title: Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.
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.
- Conditions
- Response to Hyperoxia
- Being tested
- Fraction of inspired oxygen 40%, Fraction of inspired oxygen 80%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraction of inspired oxygen 40%Other
Fraction of inspired oxygen 80%Other
| Study group | Role | What they receive |
|---|---|---|
| 40% oxygen | Active comparator | Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery. Receives: 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. Receives: Other: Fraction of inspired oxygen 80% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (1)
Hemodynamics
The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Response to HyperoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
- Investigators
- Yalim Dikmen, Prof., Study director, Cerrahpasa Medical Faculty Chairman of Intensive Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793454
- Sponsor's protocol ID
- 36048
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2013
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1017/s0265021504003102.
PubMed 15055896
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT01793454
- Acronym / sponsor ID
- 36048
- Conditions
- Response to Hyperoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40% oxygen | Active comparator | Other: Fraction of inspired oxygen 40%Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery. |
| 80% oxygen | Active comparator | Other: Fraction of inspired oxygen 80%Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing abdominal surgery, between 20-60 years old, with American Society of Anesthesiology score I or II
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fraction of inspired oxygen 40% | Other | 40% oxygen |
| Fraction of inspired oxygen 80% | Other | 80% oxygen |
Primary outcome
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
1 secondary outcome
Hemodynamics
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Background: PubMed 15055896Koksal 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yalim Dikmen, Prof. study director
Cerrahpasa Medical Faculty Chairman of Intensive Care Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraction of inspired oxygen 40% and Fraction of inspired oxygen 80% in people with Response to Hyperoxia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxidant and antioxidant response (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.