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临床试验/NCT07000760
NCT07000760已完成3 期

Intraoperative Nebulization of Lidocaine and Postoperative Pulmonary Complications

Jun Zhang2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2025年6月6日最近更新:
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
270
试验地点
2
主要终点
The incidence of PPCs within seven days after surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have signed the informed consent form and are willing to complete the study according to the protocol
  • Age ≥18 years old and ≤90 years old
  • ASA classification grades I-III
  • Elective major non-cardiac surgery
  • General anesthesia under tracheal intubation
  • Monitor invasive arterial blood pressure
  • The expected operation time ≥2 hours

排除标准

  • Untreated ischemic heart disease Severe cardiovascular and cerebrovascular diseases
  • Severe asthma, pulmonary bullae, pneumothorax, bronchopleural fistula, etc
  • Severe underlying liver and kidney diseases
  • Age under 18 years old or over 90 years old
  • The expected operation time is ≥2 hours

研究组 & 干预措施

saline

Placebo Comparator

After anesthetic induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized.

干预措施: Nebulization of normal saline (Drug)

lidocaine

Experimental

After anesthetic induction and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively.

干预措施: Nebulization of lidocaine (Drug)

结局指标

主要结局

The incidence of PPCs within seven days after surgery

时间窗: Up to one week

次要结局

  • ICU admission rate(Up to one week)
  • Hospital stay(Perioperative)
  • Postoperative pain score(Up to one week)

研究者

发起方
Jun Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jun Zhang

Professor

Fudan University

研究点 (2)

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