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NOT YET RECRUITING
NCT07499154
PHASE4

Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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