Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS)

Beth Israel Lahey Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postoperative Pulmonary Complications; Inflammatory Lung Injury; Ischemia-Reperfusion Lung Injury

Treatments: Drug: Propofol; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02918877

2016P000306

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Inhaled Anesthesia

Experimental group

Description:

Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.

Treatment:

Drug: Sevoflurane

Intravenous Anesthesia

Active Comparator group

Description:

Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.

Treatment:

Drug: Propofol