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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 dysfunction
Therapeutic 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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
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