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Assessment of Oxidative Stress during General Anesthesia

Evaluation of oxidative stress associated with the administration of two different concentrations of oxygen for the maintenance of general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002214-13-ES
Enrollment
60
Registered
2013-10-02
Start date
2013-10-28
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anesthesia and oxidative stress

Interventions

Trade Name: OXÍGENO MEDICINAL LINDE, gas medicinal criogénico, 99,5% v/v, en recipientes criogénicos móviles Pharmaceutical Form: Inhalation vapour, liquid

Sponsors

Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Any decompensated or poorly controlled disease. Women who are pregnant.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Plasma levels of glutation and advanced products of protein oxidation;Timepoint(s) of evaluation of this end point: 1 hour

Countries

Spain

Contacts

Public ContactRomy Rodríguez

Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau

RRodriguezMu@santpau.cat34939329190001969

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026