Anesthetics to Prevent Lung Injury in Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.

Detailed Description
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Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.

Official Title
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Anesthetics to Prevent Lung Injury in Cardiac Surgery

Conditions
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Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury, Postoperative Pulmonary Complications

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age 18+) Undergoing cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Emergency surgery History of severe COPD, emphysema, or ILD Recent (<2wk) or current use of systemic glucocorticoids Prior history of pneumothorax Allergy/contraindication to intravenous anesthetics Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled Anesthesia<br>Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. | Drug: Sevoflurane<br>* Volatile Anesthetic<br>|
| Active Comparator: Intravenous Anesthesia<br>Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. | Drug: Propofol<br>* Intravenous Anesthetic<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Postoperative Pulmonary Complications | Composite endpoint of clinically relevant pulmonary complications | Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up. | 
| BAL Concentration of IL1b (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass | 
| BAL Concentration of IL6 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass | 
| BAL Concentration of IL8 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass | 
| BAL Concentration of MCP1 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass | 
| BAL Concentration of sRAGE (pg/mL) | Biomarker of lung injury (RAGE - receptor for advance glycosylation end products) | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volatile Anesthetics, Intravenous Anesthetics, Inflammatory Lung Injury, Postoperative Pulmonary Complications, Cardiac Surgery, Cardiopulmonary Bypass