Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The Children's Hospital of Zhejiang University School of Medicine
- Trial code
- NCT07499154
- Record updated
- 30 March 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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).
Exclusion: Concomitant continuous infusion of another local anesthetic; 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; Known or suspected allergy to lidocaine; Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia; Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function; Multiple malformations, chromosomal abnormalities, or immunodeficiency; ASA physical status IV or higher; Severe malnutrition expected to substantially impair postoperative recovery; Severe hepatic or renal dysfunction; Current or recent participation in another interventional clinical trial in its active intervention phase.