[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631321":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":26,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidocaine Group","EXPERIMENTAL","Participants receive intravenous lidocaine beginning at the surgery, with a loading infusion over 20 minutes followed by continuous infusion for 24 hours.",[13],"Drug: Lidocaine %2 ampoule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants receive volume-matched intravenous normal saline placebo beginning at the surgery, with the same administration schedule as the active intervention.",[19],"Drug: Normal Saline (0.9% NaCl)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lidocaine %2 ampoule","Intravenous lidocaine hydrochloride 2%: loading dose 1.0 mg\u002Fkg administered over 20 minutes starting at the surgery, followed by continuous infusion at 1.0 mg\u002Fkg\u002Fhour for 24 hours. Dosing is based on standard body weight or actual body weight according to protocol-defined rules.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline (0.9% NaCl)","Volume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiangming Fan, MD, PhD","CONTACT","+86 13616532813","fanxiangming@zju.edu.cn",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Children's Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310052","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.16142,30.29365,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Qian Chen, MD, PhD","+86 13883350798","qian.chen@zju.edu.cn",{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100631321","phase-4-perioperative-lidocaine-for-lung-protection-in-infants-undergoing-cardiac-surgery-100631321",false,"NCT07499154","Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery","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.","PLICS","Inclusion Criteria:\n\n1. Infants aged 0 to 12 months.\n2. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass.\n3. American Society of Anesthesiologists (ASA) physical status I to III.\n4. Written informed consent provided by parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n1. Multiple malformations, chromosomal abnormalities, or immunodeficiency.\n2. Known or suspected allergy to lidocaine.\n3. Concomitant continuous infusion of another local anesthetic.\n4. Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.\n5. ASA physical status IV or higher.\n6. Severe malnutrition expected to substantially impair postoperative recovery.\n7. Severe hepatic or renal dysfunction.\n8. Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.\n9. Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.\n10. 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.\n11. Current or recent participation in another interventional clinical trial in its active intervention phase.","ALL","12 Months",{"count":69,"type":70},320,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","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.",[76,77,78],"Congenital Heart Disease","Postoperative Pulmonary Complications","Acute Lung Injury",[80,81,82,83],"Lidocaine","Lung injury","Infant cardiac surgery","Cardiopulmonary bypass","NOT_YET_RECRUITING","2026-03-23",{"date":87,"type":88},"2026-03-30","ACTUAL",{"date":90,"type":70},"2026-04-01",{"date":92,"type":70},"2027-12-31",{"name":5,"class":6},1]