Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Lidocaine %2 ampoule: Intravenous 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): Volume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group.

Study 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.

Eligibility

Primary outcome measure(s)

• Acute Lung Injury Score within 72 hours after surgery — Assessed at 0, 12, 24, 36, 48, 60, and 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.

Trial sites (1)

More The Children's Hospital of Zhejiang University School of Medicine trials in China

Other trials for the same condition