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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619214
Acronym
OSGA
Enrollment
60
Registered
2015-12-02
Start date
2013-05-31
Completion date
2016-06-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Oxidative Stress, Oxygen, General Anesthesia

Brief 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.

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.

Sponsors

University of Barcelona
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Malondialdehyde levelBaseline and after one hour of general anesthesiaA 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.

Secondary

MeasureTime frameDescription
Change in proteic oxidation levelBaseline and after one hour of general anesthesia.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.
Change in glutathion levelBaseline and after one hour of general anesthesia.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.

Countries

Spain

Contacts

Primary ContactSebastian Castrillon, M.D
scastrillon@santpau.cat00 34 935537541

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026