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Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
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.
Official title: Evaluation of the Effect of Perioperative Lidocaine Administration on Reducing Pulmonary Injury in Infants Following Cardiac Surgery: A Randomized, Placebo-Controlled, Double-Blind, Multi-center Superiority Trial.
Key Details
Gender
All
Age Range
Any - 12 Months
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-04-01
Completion Date
2027-12-31
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
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.
Locations (1)
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China