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Cardioprotective effect of sevoflurane versus propofol used during anesthesia and the postoperative period in patients undergoing coronary bypass surgery. Impact on critical care unit stay. A double-blind, randomized, controlled, prospective clinical study.Efecto cardioprotector del sevoflurano frente al propofol, utilizados durante la anestesia y el periodo postoperatorio en pacientes sometidos a cirugía de bypass coronario. Repercusión sobre la estancia en la unidad de críticos. Estudio clínico, prospectivo, controlado, randomizado y doble ciego.

Conditions
This study will evaluate the cardioprotective effects of sevoflurane versus propofol during anesthesia and sedation of patients undergoing coronary bypass surgery in terms of maintenance of cardiac function and reduction of stay in these units.Secondary Objectives:1. To compare the possible advantages and disadvantages of both regimens in terms of preservation/improvement or pulmonary, hepatic and renal side effects.
MedDRA version: 8.1Level: LLTClassification code 10002323Term: Anesthesia general
Registration Number
EUCTR2006-003515-44-ES
Lead Sponsor
FRANCISCO JAVIER BELDA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Signed informed consent (patient or relatives)
2. Aged 18 years or older
3. Minimum postoperative sedation of 4 hours
4. Patients scheduled for elective coronary surgery.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior coronary or valvular surgery
2. Combined surgery (simultaneous carotid endartectomy, valvular repair, left ventricular aneurysmectomy)
3. Unstable angina
4. Valvular insufficiency
5. Myocardial infarction in the last 6 weeks
6. Active congestive heart failure
7. Hemodynamic instability requiring pharmacologic or mechanical support
8. Renal dysfunction: Creatinine > 1.5 mg/dL
9. Hepatic dysfunction: GOT, GPT > 150 U/L
10. Severe chronic obstructive pulmonary disease (FEV1 < 50% or < 2 L)
11. History of chronic enolism or neurological disease
12. Pregnant or lactating women

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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