Assessment of Oxidative Stress during General Anesthesia
Phase 1
- Conditions
- General anesthesia and oxidative stressTherapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]
- Registration Number
- EUCTR2013-002214-13-ES
- Lead Sponsor
- Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients scheduled for elective surgery at the Hospital de la Santa Creu i Sant Pau, ASA 2 or lower, aged between 25 and 50 years, of both sexes.
Surgeries where are not expected ventilatory alterations of hemodynamics or major internal environment. This includes ENT surgery, plastic surgery and neck surgery.
Surgery with an expected duration of more than 60 minutes.
Maintenance anesthesia with sevoflurane.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Any decompensated or poorly controlled disease.
Women who are pregnant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the development of oxidative stress in relation to two oxygen doses frequently administered by anesthesiologists in daily practice, and in situations where surgical conditions are not the main determinant of oxidative stress;Secondary Objective: Not applicable;Primary end point(s): Plasma level of malondialdehide.;Timepoint(s) of evaluation of this end point: 1 hour
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Plasma levels of glutation and advanced products of protein oxidation;Timepoint(s) of evaluation of this end point: 1 hour