Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this 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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Lidocaine %2 ampoule
  • Normal Saline (0.9% NaCl)

Treatment groups

320 Participants
are divided into 2 treatment groups