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Clinical Trials/NCT02672345
NCT02672345
Completed
N/A

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

Instituto Dante Pazzanese de Cardiologia1 site in 1 country100 target enrollmentAugust 2016

Overview

Phase
N/A
Intervention
Sevoflurane
Conditions
Inflammatory Response
Sponsor
Instituto Dante Pazzanese de Cardiologia
Enrollment
100
Locations
1
Primary Endpoint
Reduction of systemic inflammatory response
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
June 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thiago Augusto Azevedo Maranhão Cardoso

MD

Instituto Dante Pazzanese de Cardiologia

Eligibility Criteria

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)

Arms & Interventions

Sevoflurane Group

Group of patients receiving sevorane during extracorporeal circulation period.

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Reduction of systemic inflammatory response

Time Frame: Through study completion, an average of 1 year

Cytokines 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.

Study Sites (1)

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