Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Congenital Heart Disease, Postoperative Pulmonary Complications, Acute Lung Injury

In brief

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.

Key facts

Study ID

NCT07499154

Run by

The Children's Hospital of Zhejiang University School of Medicine

People needed

320

Starts

2026-04-01

Expected to finish

2027-12-31

Last updated by the study team

2026-03-30

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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