Assessing the potential benefit of the use of sevoflurane as an anesthetic during bypass surgery and subsequent recovery
- Conditions
- Assessment of the beneficial effects of sevoflurane during the intraoperative and immediate postoperative myocardial revascularization surgery. Assessment will be through biochemical markers of myocardial injury and dysfunctionTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-001304-11-ES
- Lead Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- 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. Elective off-pump CABG.
2.EUROSCORE (European level of risk, useful in the perioperative period of cardiac surgery patients, validated medical and scientific level) under 8 (moderate risk in the perioperative cardiac).
3. Anesthetic risk level according to the American Society of Anesthesia (ASA) of less than 4 (moderate anesthetic risk patient-high).
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. History of adverse reaction to the various anesthetic drugs.
2. Severe disease of any organ (lung, liver, kidney), diagnosed preoperatively.
3. Combined surgery (eg valve repair or carotid surgery).
4. Patients in hemodynamic instability.
5. Heart failure or need for use of inotropes or vasoactive before surgery.
6. Treatment with oral antidiabetics suspended at least 48 hours before.
7. Treatment eufilina / theophylline before surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Knowledge of the mechanisms by which myocardial protection occurs in both intraoperatively and postoperatively, determining which of the different effector pathways of preconditioning and postconditioning<br><br>Determine length of stay in the intensive care unit of each of the groups to determine if the potentiation of the effect through the postoperative administration, reduces per se the stay in the intensive care unit<br><br>Identify differences in rhythm disorder episodes (tachyarrhythmias), thanks mainly to the effects of postconditioning, and the biochemical basis of this beneficial effect;Primary end point(s): Damage and myocardial injury (NT-proBNP levels, troponinaI, CK and CKMMB);Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit;Main Objective: To assess the effects of sevoflurane on intra-and postoperative patients undergoing myocardial revascularization surgery compared to propofol in terms of harm reduction and myocardial injury
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Cardiac rhythm disorder episodes<br>Days of stay in the intensive care unit;Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit