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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Unknown; Phase 4

Conditions: Oxidative Stress

Treatments: Drug: 60% of oxygen concentration.; Drug: 30% of oxygen concentration.

Study type: Interventional

Funder types: Other

Identifiers

NCT02619214

IIBSP-OXI-2013-62

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Oxygen 30%

Experimental group

Description:

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

Treatment:

Drug: 30% of oxygen concentration.

Oxygen 60%

Experimental group

Description:

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

Treatment:

Drug: 60% of oxygen concentration.