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Oxidative StressPhase 4OSGANCT02619214

Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.

A Phase 4 study testing 30% of oxygen concentration. and 60% of oxygen concentration. in people with Oxidative Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clinical trial controlled randomized of parallels groups. The study is designed to look for differences in the oxidative stress level among healthy patients receiving 2 different oxygen concentrations: 30% and 60% during general anesthesia. Read more about this study

Who is it for?
Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Oxidative Stress
What is being tested?
30% of oxygen concentration. and 60% of oxygen concentration.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
May 2013to Jun 2016
Phase
Phase 4
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 25 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Elective surgery, under general anesthesia.
  • ASA 1 - 2
  • Orl surgery, reconstructive surgery, neck surgery, abdominal wall surgery.

Who cannot join

  • Smoking Habit
  • Pregnancy
  • No compensated disease.
  • ASA 3 or Higher.

Trial locations and contacts

1 site in 1 country.

Sebastian Castrillon, M.D contact

00 34 935537541

scastrillon@santpau.cat

Spain1 site, 1 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025

    Sebastian Castrillon, M.D., 00(34) 935 537 541, scastrillon@santpau.cat

    Nadia Llavero, (0034) 93 553 76 35 ext. 7635, nllavero@santpau.cat

    Recruiting

Other trials in Spain

About this study

Clinical trial controlled randomized of parallels groups. The study is designed to look for differences in the oxidative stress level among healthy patients receiving 2 different oxygen concentrations: 30% and 60% during general anesthesia. Once the patient has been informed, the affirmative agreement has been obtained and inclusion and exclusion criteria verified the patients are randomized to 30% or 60% oxygen concentration. In the operating room while placing the intravenous line, a sample blood is obtained. General anesthesia is induced and maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in order to provide the oxygen concentration according to the randomization. One hour later a second venous sample is obtained. Samples are stored in cold conditions until their analysis in the laboratories of the biology faculty - Barcelona University.

Being tested
30% of oxygen concentration., 60% of oxygen concentration.
Keywords
Oxidative Stress, Oxygen, General Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30% of oxygen concentration.Drug

    30% oxygen concentration during one hour of general anesthesia.

  • 60% of oxygen concentration.Drug

    60% oxygen concentration during one hour of general anesthesia.

Study groups in NCT02619214
Study groupRoleWhat they receive
Oxygen 30%ExperimentalPatient receives 1 hour of general anesthesia with a 30% oxygen concentration.
Receives: Drug: 30% of oxygen concentration.
Oxygen 60%ExperimentalPatient receives 1 hour of general anesthesia with a 60% oxygen concentration.
Receives: Drug: 60% of oxygen concentration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Malondialdehyde level

    A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.

    Measured: Baseline and after one hour of general anesthesia

Secondary outcomes (2)

  1. Change in proteic oxidation level

    A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.

    Measured: Baseline and after one hour of general anesthesia.

  2. Change in glutathion level

    A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.

    Measured: Baseline and after one hour of general anesthesia.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2015 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2015 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02619214
Sponsor's protocol ID
IIBSP-OXI-2013-62
Acronym
OSGA
Status last verified
Nov 2015
First submitted
25 Nov 2015
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.

    PubMed 11089981

  • Phillips M, Cataneo RN, Greenberg J, Grodman R, Gunawardena R, Naidu A. Effect of oxygen on breath markers of oxidative stress. Eur Respir J. 2003 Jan;21(1):48-51. doi: 10.1183/09031936.02.00053402.

    PubMed 12570108

  • Loiseaux-Meunier MN, Bedu M, Gentou C, Pepin D, Coudert J, Caillaud D. Oxygen toxicity: simultaneous measure of pentane and malondialdehyde in humans exposed to hyperoxia. Biomed Pharmacother. 2001 Apr;55(3):163-9. doi: 10.1016/s0753-3322(01)00042-7.

    PubMed 11325214

  • Winter PM, Smith G. The toxicity of oxygen. Anesthesiology. 1972 Aug;37(2):210-41. doi: 10.1097/00000542-197208000-00010. No abstract available.

    PubMed 4559456

  • Morita S, Snider MT, Inada Y. Increased N-pentane excretion in humans: a consequence of pulmonary oxygen exposure. Anesthesiology. 1986 Jun;64(6):730-3. doi: 10.1097/00000542-198606000-00009.

    PubMed 3717636

  • Griendling KK, FitzGerald GA. Oxidative stress and cardiovascular injury: Part I: basic mechanisms and in vivo monitoring of ROS. Circulation. 2003 Oct 21;108(16):1912-6. doi: 10.1161/01.CIR.0000093660.86242.BB. No abstract available.

    PubMed 14568884

  • Galley HF. Oxidative stress and mitochondrial dysfunction in sepsis. Br J Anaesth. 2011 Jul;107(1):57-64. doi: 10.1093/bja/aer093. Epub 2011 May 19.

    PubMed 21596843

  • Alonso de Vega JM, Diaz J, Serrano E, Carbonell LF. Plasma redox status relates to severity in critically ill patients. Crit Care Med. 2000 Jun;28(6):1812-4. doi: 10.1097/00003246-200006000-00021.

    PubMed 10890625

  • Alonso de Vega JM, Diaz J, Serrano E, Carbonell LF. Oxidative stress in critically ill patients with systemic inflammatory response syndrome. Crit Care Med. 2002 Aug;30(8):1782-6. doi: 10.1097/00003246-200208000-00018.

    PubMed 12163793

  • Khaw KS, Wang CC, Ngan Kee WD, Pang CP, Rogers MS. Effects of high inspired oxygen fraction during elective caesarean section under spinal anaesthesia on maternal and fetal oxygenation and lipid peroxidation. Br J Anaesth. 2002 Jan;88(1):18-23. doi: 10.1093/bja/88.1.18.

    PubMed 11883375

  • Khaw KS, Ngan Kee WD, Chu CY, Ng FF, Tam WH, Critchley LA, Rogers MS, Wang CC. Effects of different inspired oxygen fractions on lipid peroxidation during general anaesthesia for elective Caesarean section. Br J Anaesth. 2010 Sep;105(3):355-60. doi: 10.1093/bja/aeq154. Epub 2010 Jun 24.

    PubMed 20576633

  • Allaouchiche B, Debon R, Goudable J, Chassard D, Duflo F. Oxidative stress status during exposure to propofol, sevoflurane and desflurane. Anesth Analg. 2001 Oct;93(4):981-5. doi: 10.1097/00000539-200110000-00036.

    PubMed 11574369

  • Yagi K. Lipid peroxides and human diseases. Chem Phys Lipids. 1987 Nov-Dec;45(2-4):337-51. doi: 10.1016/0009-3084(87)90071-5.

    PubMed 3319232

  • Witko-Sarsat V, Friedlander M, Capeillere-Blandin C, Nguyen-Khoa T, Nguyen AT, Zingraff J, Jungers P, Descamps-Latscha B. Advanced oxidation protein products as a novel marker of oxidative stress in uremia. Kidney Int. 1996 May;49(5):1304-13. doi: 10.1038/ki.1996.186.

    PubMed 8731095

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 30% of oxygen concentration. and 60% of oxygen concentration. in people with Oxidative Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 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 Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sebastian Castrillon, M.D (00 34 935537541, scastrillon@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Malondialdehyde level (time frame: Baseline and after one hour of general anesthesia). 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 NCT02619214, which also lists 14 linked publications.

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 2 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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