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

NCT ID: NCT02672345

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Inflammatory Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sevoflurane Group

Group of patients receiving sevorane during extracorporeal circulation period.

Sevoflurane

Intervention Type DRUG

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.

Not Sevoflurane Group

Group of patients who did not receive the sevorane during extracorporeal circulation period.

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role lead

Responsible Party

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Thiago Augusto Azevedo Maranhão Cardoso

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thiago Augusto Azevedo Maranhão Cardoso

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Cardoso TAAM, Kunst G, Neto CN, de Ribamar Costa Junior J, Silva CGS, Bastos GM, Borges JB, Hirata MH. Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):25. doi: 10.1186/s13063-020-04809-x.

Reference Type DERIVED
PMID: 33407763 (View on PubMed)

Other Identifiers

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4617

Identifier Type: -

Identifier Source: org_study_id

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