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.
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).
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.
Parallel
Lidocaine %2 ampoule
DrugIntravenous lidocaine hydrochloride 2%: loading dose 1.0 mg/kg administered over 20 minutes starting at the surgery, followed by continuous infusion at 1.0 mg/kg/hour for 24 hours. Dosing is based on standard body weight or actual body weight according to protocol-defined rules.
Normal Saline (0.9% NaCl)
DrugVolume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group.
Acute Lung Injury Score within 72 hours after surgery
Composite lung injury severity score ranging from 0 to 4, based on oxygenation index or oxygen saturation index, chest radiograph findings, positive en-expiratory pressure, and pulmonary compliance. Higher scores indicate more severe lung injury.
Arterial partial pressure of oxygen
Measured by arterial blood gas analysis, reported in mmHg.
Arterial partial pressure of carbon dioxide
Measured by arterial blood gas analysis, reported in mmHg.
Arterial oxygen saturation
Measured by arterial blood gas analysis, reported as percentage (%).
Arterial lactate concentration
Measured by arterial blood gas analysis, reported in mmol/L.
Postoperative sedative and analgesic use
Total cumulative dose and frequency of administration of postoperative sedative and analgesic medications administered during the first 72 hours after surgery, as recorded in the medication administration record.
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