Clinical trial NCT02619214: Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.
Official title: Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oxidative Stress
Keywords: Oxidative Stress
Oxygen
General Anesthesia
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2015-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Malondialdehyde level
timeFrame: Baseline and after one hour of general anesthesia
Secondary outcomes:
measure: Change in proteic oxidation level
timeFrame: Baseline and after one hour of general anesthesia.
measure: Change in glutathion level
timeFrame: Baseline and after one hour of general anesthesia.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
Study officials:
affiliation: Anesthesiologist.
name: Sebastian Castrillon, M.D.
role: PRINCIPAL_INVESTIGATOR
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