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: 8.1 Level: LLT Classification code 10002323 Term: Anesthesi
Conditions
Interventions
Trade Name: SEVORANE
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: SEVOFLURANO
Other descriptive name: SEVOFLURANO
Concentration unit: % percent
Concentration type: equal
Concent
Sponsors
FRANCISCO JAVIER BELDA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To 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 Objective: 1. To compare the quality of the anesthesia and sedation obtained with sevoflurane versus that obtained with propofol in terms of control of anesthesia and sedation, rapidity and predictability of emergence in critical care patients. 2. To determine the mean alveolar concentration of sevoflurane required to obtain an adequate level of anesthesia and sedation in these patients. 3. To compare the possible advantages and disadvantages of both regimens in terms of preservation/improvement or pulmonary, hepatic and renal side effects.;Primary end point(s): To 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. | — |
Countries
Spain
Outcome results
None listed