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Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB

Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02672345
Enrollment
100
Registered
2016-02-03
Start date
2016-08-31
Completion date
2020-06-30
Last updated
2020-06-23

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

Conditions

Inflammatory Response

Keywords

Sevoflurane, MicroRNAs, Inflammatory Response, Cytokines, Anesthetics, Inhalation, Macrophage Inflammatory Proteins

Brief summary

Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a feature that allowed more precision and tranquility to the heart surgeon. But their influence on exacerbation of inflammatory response can unbalance the whole homeostasis so happens surgical trauma. The attenuation of the systemic inflammatory response in major surgeries like cardiac surgery for aortic aneurysm appears to represent an important advance in reducing morbidity and mortality of these patients. Some studies suggest that inhaled anesthetics such as sevoflurane appear to play an important role in this control, but the mechanism by which this happens is still unclear. This study has the primary purpose of analyzing from a clinical study sevoflurane inhalation anesthetic can change the inflammatory response induced by CPB, significantly reducing the release of inflammatory markers, especially elastase PMN.

Interventions

DRUGSevoflurane

The Sevoflurane Group will receive between 0.7 and 1.5% of sevoflurane CAM only during CPB period. While Not Sevoflurane Group will receive only intravenous anesthetic agents.

Sponsors

Instituto Dante Pazzanese de Cardiologia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 18 years * Cardiac Surgery elective of coronary artery bypass graft with cardiopulmonary bypass (CPB) * The informed consent signature savvy

Exclusion criteria

* Use of steroids or anti-inflammatory drugs routine * Presence of asthma, COPD, autoimmune diseases * Participation in other clinical studies * Presence of decompensated heart failures, liver or kidney * Combined elective surgery (ex .: aneurysm correction + CABG) * Acute myocardial infarction in the last 30 days * Unstable angina * And obesity (BMI\> 50kg / m2)

Design outcomes

Primary

MeasureTime frameDescription
Reduction of systemic inflammatory responseThrough study completion, an average of 1 yearCytokines are assayed in both groups at 4 different times in order to check the impact of sevoflurane on the inflammatory response. The first one is the baseline of measurement with which the others are compared and all will be compared within and between groups.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026