Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Phase 4Not Yet RecruitingNCT07499154

The Children's Hospital of Zhejiang University School of Medicine320 enrolled

Overview

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.

Infants undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary injury due to systemic inflammatory activation, ischemia-reperfusion injury, and disruption of the alveolar-capillary barrier. Intravenous lidocaine has been reported to exert anti-inflammatory, anti-arrhythmic, and potential organ-protective effects. However, evidence in infants undergoing cardiac surgery remains limited. This randomized, double-blind, placebo-controlled superiority trial will enroll infants aged 0 to 12 months scheduled for corrective, non-palliative congenital cardiac surgery with cardiopulmonary bypass at a tertiary pediatric center. Participants will be randomized in a 1:1 ratio to receive either perioperative intravenous lidocaine or volume-matched normal saline placebo. The trial will assess postoperative pulmonary injury severity over the first 72 hours after surgery, together with respiratory, laboratory, echocardiographic, and safety outcomes until postoperative day 7 or at discharge.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

320

Interventions

Lidocaine %2 ampouleDRUG

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.

Eligibility

Sex: ALLMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: 1. Infants aged 0 to 12 months. 2. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass. 3. American Society of Anesthesiologists (ASA) physical status I to III. 4. Written informed consent provided by parent(s) or legal guardian(s). Exclusion Criteria: 1. Multiple malformations, chromosomal abnormalities, or immunodeficiency. 2. Known or suspected allergy to lidocaine. 3. Concomitant continuous infusion of another local anesthetic. 4. Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia. 5. ASA physical status IV or higher. 6. Severe malnutrition expected to substantially impair postoperative recovery. 7. Severe hepatic or renal dysfunction. 8. Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function. 9. Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection. 10. 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. 11. Current or recent participation in another interventional clinical trial in its active intervention phase.

Outcomes

Primary Outcomes

Acute Lung Injury Score within 72 hours after surgery

Composite lung injury severity score ranging from 0 to 4, based on oxygenation index or oxygen saturation index, chest radiograph findings, positive en-expiratory pressure, and pulmonary compliance. Higher scores indicate more severe lung injury.

Time frame: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery

Secondary Outcomes

Arterial partial pressure of oxygen

Measured by arterial blood gas analysis, reported in mmHg.

Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery

Arterial partial pressure of carbon dioxide

Measured by arterial blood gas analysis, reported in mmHg.

Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery

Arterial oxygen saturation

Measured by arterial blood gas analysis, reported as percentage (%).

Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery

Arterial lactate concentration

Measured by arterial blood gas analysis, reported in mmol/L.

Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery

Duration of mechanical ventilation

Total duration of invasive mechanical ventilation, measured in hours, from postoperative admission to the intensive care unit until first successful extubation without the need for reintubation.

Time frame: From postoperative ICU admission until successful discontinuation of invasive mechanical ventilation, assessed up to 72 hours after surgery.

PICU length of stay

Duration of stay in the pediatric intensive care unit, measured in days.

Time frame: From postoperative admission to the pediatric intensive care unit until discharge from the pediatric intensive care unit, assessed up to 7 days after surgery.

Left ventricular ejection fraction (LVEF)

Left ventricular fractional shortening assessed by transthoracic echocardiography, reported as percentage (%).

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma lidocaine concentration

Plasma lidocaine concentration measured using the assay specified in the study laboratory manual, reported in ug/mL

Time frame: 6, 12, 18, 24 hours after surgery

Incidence of postoperative pulmonary complications

Incidence of at least one postoperative pulmonary complication within 72 hours after surgery, defined as the occurrence of any of the following: atelectasis, pulmonary edema, pleural effusion, pneumothorax, or infectious pneumonia. Reported as the percentage of participants with at least one postoperative pulmonary complication.

Time frame: Assessed within 72 hours after surgery

Prothrombin time (PT)

Measured in venous blood by routine clinical laboratory testing, reported in seconds.

Time frame: Baseline, 24, 48, and 72 hours after surgery

Activated partial thromboplastin time (aPTT)

Measured in venous blood by routine clinical laboratory testing, reported in seconds.

Time frame: Baseline, 24, 48, and 72 hours after surgery

Alanine aminotransferase (ALT)

Measured by routine clinical laboratory testing, reported in U/L.

Time frame: Baseline, 24, 48, and 72 hours after surgery

Aspartate aminotransferase (AST)

Measured by routine clinical laboratory testing, reported in U/L.

Time frame: Baseline, 24, 48, and 72 hours after surgery

Serum creatinine

Measured by routine clinical laboratory testing, reported in umol/L.

Time frame: Baseline, 24, 48, and 72 hours after surgery

Blood urea nitrogen

Measured by routine clinical laboratory testing, reported in mmol/L.

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma soluble intercellular adhesion molecule-1 (sICAM-1) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma surfactant protein D (SP-D) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma soluble receptor for advanced glycation end products (sRAGE) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma interleukin-1 beta (IL-1β) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma angiopoietin-2 concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma double-stranded DNA (dsDNA) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma high-mobility group box 1 (HMGB1) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma neurofilament light chain (NFL) concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Plasma S100B concentration

Measured using ELISA assay kit, reported in umol/L

Time frame: Baseline, 24, 48, and 72 hours after surgery

Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts