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

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672345
• Other study ID #: 4617
• Status: Completed
• Start date: August 2016
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

Drug:
• Sevoflurane
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.

Locations

Country	Name	City	State
Brazil	Thiago Augusto Azevedo Maranhão Cardoso	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of systemic inflammatory response	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.	Through study completion, an average of 1 year