Abstract / Summary
Despite the lung-protective ventilation strategy, high incidence of postoperative pulmonary complications (PPCs) after major non-cardiac surgery remains a major concern in the perioperative care due to high morbidity and mortality. The study aimed to evaluate the efficacy and safety of intraoperative nebulized lidocaine on PPCs in major abdominal surgery. Adults scheduled for major abdominal surgery were enrolled and randomised 1:1 into two groups from June 6, 2025, to January 23, 2026, and final follow-up was in January 30, 2026. Patients in the intervention group received nebulized lidocaine twice: once immediately after anesthesia induction and again before the end of surgery, with 100 mg of 2% lidocaine administered each time. Patients in the control group received same volume of normal saline as a placebo. The primary outcome was a composite of pulmonary complications within the first postoperative 7 days, including severe respiratory failure, bronchospasm, suspected pulmonary infection, aspiration pneumonitis, atelectasis, pleural effusion, and pneumothorax. The secondary outcomes included a range of clinical measures, including intraoperative fluid balance, use of any vasoactive agents, postoperative pain score, new-onset arrhythmias, postoperative extrapulmonary complications (comprising septic shock, extrapulmonary infection, and anastomotic leakage), unplanned intensive care unit admission, hospital length of stay, Clavien-Dindo classification of surgical complications, and all-cause in-hospital mortality. A total of 270 patients was randomised and finally 262 patients completed the study and were analyzed (130 control, 132 intervention, 106 female patients [40.5%]; mean [SD] age, 60.4 [11.9] years). In the primary analysis population, PPCs occurred in 41 of 132 patients (31.1%) in the intervention group compared with 37 of 130 patients (28.5%) in the control group (absolute difference, 2.6% [95% CI, -8.5% to 13.7%]; P = 0.686). There was no significant difference in any of secondary endpoints between the two groups. Among patients undergoing major abdominal surgery, intraoperative nebulized 2% lidocaine was safe but did not reduce the incidence of PPCs. Registered at ClinicalTrials.gov (Registration No. NCT07000760 Principal investigator Jun Zhang Date of registration 05/22/2025 https://clinicaltrials.gov/study/NCT07000760?term=NCT07000760&rank=1 ).