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

November 30, 2015 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxygen 30%
Patient receives 1 hour of general anesthesia with a 30% oxygen concentration.
Drug: 30% of oxygen concentration.
30% oxygen concentration during one hour of general anesthesia.
EXPERIMENTAL: Oxygen 60%
Patient receives 1 hour of general anesthesia with a 60% oxygen concentration.
Drug: 60% of oxygen concentration.
60% oxygen concentration during one hour of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Malondialdehyde level
Time Frame: 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.
Baseline and after one hour of general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proteic oxidation level
Time Frame: 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.
Baseline and after one hour of general anesthesia.
Change in glutathion level
Time Frame: 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.
Baseline and after one hour of general anesthesia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of Barcelona

Investigators

  • Principal Investigator: Sebastian Castrillon, M.D., Anesthesiologist.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (ESTIMATE)

December 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-OXI-2013-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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