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
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
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
Name Time Method
- Secondary Outcome Measures
Name Time Method