Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07499154
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Lung Injury
  • Congenital Heart Disease
  • Postoperative Pulmonary Complications

Eligibility Criteria

Sex
ALL
Age
N/A - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine %2 ampoule — DRUG
    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) — DRUG
    Volume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group.

Study Details

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 Dates

First listed
Mar 30, 2026
Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Lidocaine Group
    Participants receive intravenous lidocaine beginning at the surgery, with a loading infusion over 20 minutes followed by continuous infusion for 24 hours.
  • Placebo Comparator: Placebo Group
    Participants receive volume-matched intravenous normal saline placebo beginning at the surgery, with the same administration schedule as the active intervention.

Primary Outcome Measure

Acute Lung Injury Score within 72 hours after surgery [ Time Frame: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery ]

Central Contacts

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