Yang Chun, Zhuang Min-Yuan, Chen Xian, Shui Xiao-Feng, Peng Hui-Ping, Hu Jing-Hui, Liu Hong, Ji Fu-Hai, Peng Ke
Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China.
BMJ Open. 2025 Apr 27;15(4):e088092. doi: 10.1136/bmjopen-2024-088092.
Postoperative delirium (POD) is a frequent complication in elderly surgical patients, leading to increased morbidity and mortality. Previous studies have shown that noise isolation is associated with a reduced incidence of delirium in the intensive care unit (ICU). This trial aims to evaluate the impact of noise isolation using noise-cancelling headphones on the incidence of POD in elderly patients undergoing hip surgery.
In this randomised controlled trial, a total of 320 elderly patients will be randomised to a noise isolation group or a control group, in a 1:1 ratio and stratified by age (65‒80 years or >80 years), type of surgery (fracture or non-fracture) and planned ICU admission (yes or no). For patients in the noise isolation group, noise-cancelling headphones will be used throughout anaesthesia and in the postoperative care unit or ICU. Patients in the control group will be routinely managed and exposed to the clinical environment. The primary outcome is the incidence of POD during 0‒7 days after surgery or before hospital discharge, assessed using the 3 min Confusion Assessment Method or the Confusion Assessment Method for the Intensive Care Unit. The secondary outcomes include postoperative pain at 6, 24 and 48 hours after surgery; sleep quality on the first and second nights after surgery; incidence of nausea and vomiting within 48 hours postoperatively; and cognitive function and mortality at 30 days after surgery.
The trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024-054). The results of this trial will be submitted for peer review and publication in a scientific journal.
Chinese Clinical Trial Registry (ChiCTR2400082211).
术后谵妄（POD）是老年外科患者常见的并发症，会导致发病率和死亡率上升。既往研究表明，在重症监护病房（ICU）中，噪声隔离与谵妄发生率降低有关。本试验旨在评估使用降噪耳机进行噪声隔离对接受髋关节手术的老年患者POD发生率的影响。
在这项随机对照试验中，总共320名老年患者将按1:1的比例随机分为噪声隔离组或对照组，并按年龄（65 - 80岁或>80岁）、手术类型（骨折或非骨折）和计划入住ICU情况（是或否）进行分层。对于噪声隔离组的患者，在整个麻醉期间以及术后护理单元或ICU中都将使用降噪耳机。对照组的患者将接受常规管理并暴露于临床环境中。主要结局是术后0至7天或出院前POD的发生率，使用3分钟意识模糊评估法或重症监护病房意识模糊评估法进行评估。次要结局包括术后6、24和48小时的术后疼痛；术后第一晚和第二晚的睡眠质量；术后48小时内恶心和呕吐的发生率；以及术后30天的认知功能和死亡率。
该试验已获得苏州大学附属第一医院伦理委员会批准（批准号：2024 - 054）。本试验结果将提交同行评审并发表在科学期刊上。
中国临床试验注册中心（ChiCTR2400082211）
