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

Completed

• Conditions: Inflammatory Response
• Interventions: Drug: Sevoflurane

• Registration Number: NCT02672345
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Study Start: 2016-08
• Status Verified: 2020-06
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-20
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevoflurane Group	Sevoflurane	Group of patients receiving sevorane during extracorporeal circulation period.

Primary Outcome Measures

Name	Time	Method
Reduction of systemic inflammatory response	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.

Trial Locations

Locations (1)

Thiago Augusto Azevedo Maranhão Cardoso; 🇧🇷 São Paulo, Brazil