Phase 2 N=49 Randomized Single-blind Prevention

Anesthetics to Prevent Lung Injury in Cardiac Surgery

Inflammatory Lung Injury · Ischemia-Reperfusion Lung Injury · Postoperative Pulmonary Complications

Bottom Line

View on ClinicalTrials.gov: NCT02918877 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) — 0.53; 0.53; 22.06; 102.04 pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sevoflurane (Drug); Propofol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)	0.53; 0.53; 22.06; 102.04; 17.24; 101.51	—
SECONDARY Number of Patients With Postoperative Pulmonary Complications	0; 3; 0; 1; 0; 2	—
SECONDARY BAL Concentration of IL1b (pg/mL)	0.42; 0.87; 8.56; 14.37; 8.30; 11.00	—
SECONDARY BAL Concentration of IL6 (pg/mL)	30.70; 31.35; 275.19; 297.35; 220.68; 259.32	—
SECONDARY BAL Concentration of IL8 (pg/mL)	2008.50; 6528.50; 8019.50; 27789.50; 4701.00; 16230.00	—
SECONDARY BAL Concentration of MCP1 (pg/mL)	509.50; 977.50; 496.00; 883.50; 148.00; 479.50	—
SECONDARY BAL Concentration of sRAGE (pg/mL)	156.50; 164; 597.00; 465.00; 402.50; 224.50	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02918877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.