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

NCT02672345 | Completed DMC

• 1 other identifier: 4617
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sevoflurane Group

Group of patients receiving sevorane during extracorporeal circulation period.

Drug: Sevoflurane

Not Sevoflurane Group

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

Interventions

Sevoflurane 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.

Sevoflurane Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Will be selected 100 patients who underwent cardiac surgery of coronary artery bypass graft electively in Dante Pazzanese Institute of Cardiology (IDPC).

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

Study Sites (1)

Thiago Augusto Azevedo Maranhão Cardoso

São Paulo, 01423020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33407763 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 3, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

BR (1)