Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Infants undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary injury due to systemic inflammatory activation, ischemia-reperfusion injury, and disruption of the alveolar-capillary barrier. Intravenous lidocaine has been reported to exert anti-inflammatory, anti-arrhythmic, and potential organ-protective effects. However, evidence in infants undergoing cardiac surgery remains limited.

This randomized, double-blind, placebo-controlled superiority trial will enroll infants aged 0 to 12 months scheduled for corrective, non-palliative congenital cardiac surgery with cardiopulmonary bypass at a tertiary pediatric center. Participants will be randomized in a 1:1 ratio to receive either perioperative intravenous lidocaine or volume-matched normal saline placebo. The trial will assess postoperative pulmonary injury severity over the first 72 hours after surgery, together with respiratory, laboratory, echocardiographic, and safety outcomes until postoperative day 7 or at discharge.

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.
• Severe hepatic or renal dysfunction.
• Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.
• Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.
• Use of medications that may interact with lidocaine or constitute an exclusion, including class I or class III antiarrhythmic agents, cimetidine, or antiviral drugs, as determined by the clinical team.
• Current or recent participation in another interventional clinical trial in its active intervention phase.