Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

NCT07499154 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-IRB-0031-P-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease; Postoperative Pulmonary Complications; Acute Lung Injury

Keywords

Lidocaine; Lung injury; Infant cardiac surgery; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (24)

• Arterial partial pressure of oxygen

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

• Arterial partial pressure of carbon dioxide

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

• Arterial oxygen saturation

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

• Arterial lactate concentration

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

• Duration of mechanical ventilation

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

Other Outcomes (1)

• Postoperative sedative and analgesic use

  0 to 72 hours after surgery

Study Arms (2)

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.

Drug: Lidocaine %2 ampoule

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.

Drug: Normal Saline (0.9% NaCl)

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.

Lidocaine Group

Normal Saline (0.9% NaCl) DRUG

Volume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group.

Placebo Group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• ASA physical status IV or higher.
• Severe malnutrition expected to substantially impair postoperative recovery.
• Severe hepatic or renal dysfunction.
• Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.
• Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.
• Current or recent participation in another interventional clinical trial in its active intervention phase.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

Related Publications (11)

• Zhang C, Foo I. Is intravenous lidocaine protective against myocardial ischaemia and reperfusion injury after cardiac surgery? Ann Med Surg (Lond). 2020 Sep 11;59:72-75. doi: 10.1016/j.amsu.2020.09.008. eCollection 2020 Nov.

  PMID: 32994986 BACKGROUND

• Gregory AJ, Arora RC, Chatterjee S, Crisafi C, Morton-Bailey V, Rea A, Salenger R, Engelman DT, Grant MC; ERAS Cardiac Working Group. Enhanced Recovery After Surgery (ERAS) cardiac turnkey order set for perioperative pain management in cardiac surgery: Proceedings from the American Association for Thoracic Surgery (AATS) ERAS Conclave 2023. JTCVS Open. 2024 Sep 6;22:14-24. doi: 10.1016/j.xjon.2024.08.018. eCollection 2024 Dec.

  PMID: 39780778 BACKGROUND

• Wang L, Wang M, Li S, Wu H, Shen Q, Zhang S, Fang L, Liu R. Nebulized lidocaine ameliorates allergic airway inflammation via downregulation of TLR2. Mol Immunol. 2018 May;97:94-100. doi: 10.1016/j.molimm.2018.03.010. Epub 2018 Mar 30.

  PMID: 29609129 BACKGROUND

• Lee JM, Suh JK, Jeong JS, Cho SY, Kim DW. Antioxidant effect of lidocaine and procaine on reactive oxygen species-induced endothelial dysfunction in the rabbit abdominal aorta. Korean J Anesthesiol. 2010 Aug;59(2):104-10. doi: 10.4097/kjae.2010.59.2.104. Epub 2010 Aug 20.

  PMID: 20740215 BACKGROUND

• Kavcic H, Jug U, Mavri J, Umek N. Antioxidant activity of lidocaine, bupivacaine, and ropivacaine in aqueous and lipophilic environments: an experimental and computational study. Front Chem. 2023 Jun 20;11:1208843. doi: 10.3389/fchem.2023.1208843. eCollection 2023.

  PMID: 37408557 BACKGROUND

• Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

  PMID: 29864216 BACKGROUND

• Simonato M, Padalino M, Vedovelli L, Carollo C, Sartori A, Vida V, Gregori D, Carnielli V, Cogo P. Effect of preoperative pulmonary hemodynamic and cardiopulmonary bypass on lung function in children with congenital heart disease. Eur J Pediatr. 2023 Jun;182(6):2549-2557. doi: 10.1007/s00431-023-04926-0. Epub 2023 Mar 18.

  PMID: 36933017 BACKGROUND

• Fischer MO, Brotons F, Briant AR, Suehiro K, Gozdzik W, Sponholz C, Kirkeby-Garstad I, Joosten A, Nigro Neto C, Kunstyr J, Parienti JJ, Abou-Arab O, Ouattara A; VENICE study group. Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2344-2351. doi: 10.1053/j.jvca.2021.12.024. Epub 2021 Dec 25.

  PMID: 35094928 BACKGROUND

• Jenke A, Yazdanyar M, Miyahara S, Chekhoeva A, Immohr MB, Kistner J, Boeken U, Lichtenberg A, Akhyari P. AdipoRon Attenuates Inflammation and Impairment of Cardiac Function Associated With Cardiopulmonary Bypass-Induced Systemic Inflammatory Response Syndrome. J Am Heart Assoc. 2021 Mar 16;10(6):e018097. doi: 10.1161/JAHA.120.018097. Epub 2021 Mar 5.

  PMID: 33666100 BACKGROUND

• Sperotto F, Cogo P, Amigoni A, Pettenazzo A, Thiagarajan RR, Polito A. Extracorporeal Membrane Oxygenation Support for Failure to Wean From Cardiopulmonary Bypass After Pediatric Cardiac Surgery: Analysis of Extracorporeal Life Support Organization Registry Data. Crit Care Explor. 2020 Sep 15;2(9):e0183. doi: 10.1097/CCE.0000000000000183. eCollection 2020 Sep.

  PMID: 32984825 BACKGROUND

• Cholette JM, Muszynski JA, Ibla JC, Emani S, Steiner ME, Vogel AM, Parker RI, Nellis ME, Bembea MM; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Plasma and Platelet Transfusions Strategies in Neonates and Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass or Neonates and Children Supported by Extracorporeal Membrane Oxygenation: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding. Pediatr Crit Care Med. 2022 Jan 1;23(13 Supple 1 1S):e25-e36. doi: 10.1097/PCC.0000000000002856.

  PMID: 34989703 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Acute Lung Injury; Lung Injury

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Xiangming Fan, MD, PhD

CONTACT

+86 13616532813; fanxiangming@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, parents/guardians, treating clinicians, investigators, and outcome assessors/statisticians will remain blinded to treatment allocation. Study medication will be prepared by designated anesthesia staff not involved in outcome assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either intravenous lidocaine or volume-matched normal saline placebo.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)