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Status unknownNCT02619214OSGAUpdated Dec 2, 2015

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

A Phase 4 interventional study of 30% of oxygen concentration. and 60% of oxygen concentration. in Oxidative Stress, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Oxidative Stress

Keywords

  • Oxidative Stress
  • Oxygen
  • General Anesthesia
03

In context

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Smoking Habit
  • Pregnancy
  • No compensated disease.
  • ASA 3 or Higher.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Oxygen 30%

    Patient receives 1 hour of general anesthesia with a 30% oxygen concentration.

    Drug: 30% of oxygen concentration.

  • Experimental
    Oxygen 60%

    Patient receives 1 hour of general anesthesia with a 60% oxygen concentration.

    Drug: 60% of oxygen concentration.

Interventions

  • Drug30% of oxygen concentration.

    30% oxygen concentration during one hour of general anesthesia.

  • Drug60% of oxygen concentration.

    60% oxygen concentration during one hour of general anesthesia.

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline and after one hour of general anesthesia

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline and after one hour of general anesthesia.

07

Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Cataluña 08025, Spain
    Recruiting
08

References and documents

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. Erratum In: Eur Respir J. 2003 May;21(5):911. 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02619214
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
University of Barcelona
Responsible party
Sponsor
First posted
Dec 2, 2015
Start date
May 2013
Primary completion
Dec 2015 (estimated)
Completion
Jun 2016 (estimated)
Last update
Dec 2, 2015

Study contacts

Sebastian Castrillon, M.D
Contact
scastrillon@santpau.cat
00 34 935537541
Sebastian Castrillon, M.D.
principal investigator · Anesthesiologist.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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