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

Phase 4

• Conditions: Oxidative Stress
• Interventions: Drug: 30% of oxygen concentration.; Drug: 60% of oxygen concentration.

• Registration Number: NCT02619214
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2015-11
• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-30
• Last Update Submitted: 2015-11-30
• Primary Completion: 2015-12
• Study First Posted: 2015-12-02
• Last Update Posted: 2015-12-02
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen 30%	30% of oxygen concentration.	Patient receives 1 hour of general anesthesia with a 30% oxygen concentration.
Oxygen 60%	60% of oxygen concentration.	Patient receives 1 hour of general anesthesia with a 60% oxygen concentration.

Primary Outcome Measures

Name	Time	Method
Change in Malondialdehyde level	Baseline 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.

Secondary Outcome Measures

Name	Time	Method
Change in proteic oxidation level	Baseline 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 level	Baseline 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.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Cataluña, Spain