A Phase 3 interventional study of Nebulization of lidocaine and Nebulization of normal saline in Postoperative Pulmonary Complications (PPCs), sponsored by Jun Zhang. Completed at 2 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Jun Zhang · Phase 3, Interventional, and Prevention
There is high incidence of postoperative pulmonary complications (PPCs) in patients undergoing major abdominal surgeries.PPCs significantly prolongs the hospital stay of patients, increases their economic burden, and raises the mortality rates within 30 days and 1 year after surgery. The inflammatory response during the perioperative period plays an important role in the occurrence and development of PPCs. The anti-inflammatory effect of lidocaine has a potential lung protection mechanism. The purpose of this study is to explore the effect of nebulization of lidocaine on the incidence of PPCs. The investigators hypothesized that intraoperative nebulization of lidocaine could reduce the incidence of PPCs.
Introduction Globally, over 313 million surgical procedures are performed annually, with postoperative pulmonary complications (PPCs) occurring in 5-33% of cases. PPCs, the second most common postoperative complication after surgical site infections, encompass conditions such as respiratory infections, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia. These complications significantly prolong hospital stays, increase healthcare costs, and elevate 30-day and 1-year mortality rates.
Pathophysiology of PPCs PPCs are closely linked to perioperative pulmonary inflammatory responses. Mechanical ventilation during general anesthesia alters pulmonary ventilation distribution, leading to atelectasis in over 90% of patients. Atelectasis increases mechanical stress and hypoxia in collapsed lung regions while causing hyperinflation and hyperoxia in adjacent areas. These conditions promote the release of pro-inflammatory cytokines, reactive oxygen species, and leukocyte infiltration. Additionally, atelectasis-induced hypoxia and mechanical stress contribute to endothelial damage, increasing vascular permeability and protein leakage. Major abdominal and thoracic surgeries further exacerbate systemic inflammation and airway hyperreactivity, impairing alveolar epithelial barrier function and mucociliary clearance.
Lidocaine's Anti-Inflammatory and Lung-Protective Mechanisms Lidocaine has emerged as a potential therapeutic agent due to its anti-inflammatory properties. Studies indicate that it inhibits neutrophil infiltration and reduces pro-inflammatory cytokines (e.g., IL-6, TNF-α) by blocking Toll-like receptor 4/NF-κB signaling. Inhaled lidocaine has shown efficacy in murine asthma models by suppressing GATA-3 expression, eosinophilic inflammation, mucus overproduction, and airway hyperreactivity. It has also been explored as an adjunct therapy for severe COVID-19 respiratory symptoms, mitigating cytokine storms and improving outcomes. In pediatric patients, lidocaine reduces postoperative cough incidence.
Current Challenges and the Promise of Nebulization Despite its potential, lidocaine's clinical application for lung protection remains inconsistent. Intravenous administration poses risks due to narrow therapeutic windows, with fluctuating plasma concentrations potentially causing neurotoxicity or cardiotoxicity. nebulized lidocaine achieve direct anti-inflammatory effects within the pulmonary compartment.
Research Objective and Hypothesis The role of nebulization lidocaine in reducing PPCs remains underexplored. This study aims to evaluate its impact on PPC incidence within seven days post-surgery. The hypothesis is that intraoperative nebulized lidocaine administration will decrease PPC rates, offering a safer and more effective approach to perioperative lung protection.
Jun Zhang is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After anesthetic induction and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively.
Drug: Nebulization of lidocaine
After anesthetic induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized.
Drug: Nebulization of normal saline
After induction of general anesthesia and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively, and the nebulization time was 15-20 minutes each time.
Also known as: 1
After anesthesia induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized, and the nebulization time was 15-20 minutes each time.
Also known as: 2
The incidence of PPCs within seven days after surgery
Time frame: Up to one week
ICU admission rate
Time frame: Up to one week
Hospital stay
Time frame: Perioperative
Postoperative pain score
Postoperative pain was assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 represents the most severe pain.
Time frame: Up to one week
Plan to share: No — The data sets are available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Jan 2026, 7 months.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Jun Zhang