Skip to content

Assessing the potential benefit of the use of sevoflurane as an anesthetic during bypass surgery and subsequent recovery

Evaluation of myocardial and clinical beneficial effect of sevoflurane in intraoperative and postoperative myocardial revascularization surgery, compared with propofol

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-001304-11-ES
Enrollment
Unknown
Registered
2013-08-14
Start date
2014-01-02
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 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 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

MeasureTime frame
Secondary end point(s): Cardiac rhythm disorder episodes Days of stay in the intensive care unit;Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit

Countries

Spain

Contacts

Public ContactProyect Manager

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

patricia.vergara@fundacionimabis.org0034951440260

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026