Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery (NCT07499154) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery
China320 participantsStarted 2026-04-01
Plain-language summary
Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay. Lidocaine has anti-inflammatory and membrane-stabilizing properties and may attenuate perioperative lung injury. This investigator-initiated, randomized, placebo-controlled, double-blind trial will evaluate whether perioperative intravenous lidocaine reduces postoperative pulmonary injury in infants undergoing corrective non-palliative congenital cardiac surgery with cardiopulmonary bypass.
Who can participate
Age range12 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Infants aged 0 to 12 months.
✓. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass.
✓. American Society of Anesthesiologists (ASA) physical status I to III.
✓. Written informed consent provided by parent(s) or legal guardian(s).
Exclusion criteria
✕. Multiple malformations, chromosomal abnormalities, or immunodeficiency.
✕. Known or suspected allergy to lidocaine.
✕. Concomitant continuous infusion of another local anesthetic.
✕. Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.
✕. ASA physical status IV or higher.
✕. Severe malnutrition expected to substantially impair postoperative recovery.
What they're measuring
1
Acute Lung Injury Score within 72 hours after surgery
Timeframe: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Trial details
NCT IDNCT07499154
SponsorThe Children's Hospital of Zhejiang University School of Medicine