Zheng Miao, Wang Baoshan, Mao Menghan, Wu Yuling, Wang Zhenhong, Yang Liqun
Department of Anesthesiology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China.
Department of Anesthesiology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, China
BMJ Open. 2025 May 15;15(5):e097079. doi: 10.1136/bmjopen-2024-097079.
Delirium is a common complication in elderly patients after major surgeries and can lead to poor outcomes such as neurocognitive decline. Acetaminophen is one of the most widely used adjuvants for perioperative multimodal analgesia. Previous studies showed that it can effectively alleviate postoperative pain, promote opioid sparing and exert anti-neuroinflammatory response, showing strong potential for preventing postoperative delirium. We, thus, propose to test the primary hypothesis that postoperative intravenous acetaminophen would reduce delirium over 5 postoperative days in older patients following major non-cardiac surgery.
We propose a multicentre, randomised, placebo-controlled, parallel-group trial in patients aged>65 years old scheduled for non-cardiac major surgery with general anaesthesia expected to last at least 2 hours. A total of 1930 elderly patients will be enrolled and randomised at 1:1 ratio to acetaminophen or saline placebo groups, stratified by age, education level and trial site with randomsised blocking. Acetaminophen or saline will be given when the surgical suture begins at the end of surgery and, thereafter, a total of seven doses within 48 hours after surgery. Our primary outcome will be the incidence of delirium, assessed two times per day, through the fifth postoperative day. Secondary and exploratory outcomes will include pain scores with movement, total opioid consumption, severity of delirium, intensive care unit and hospital lengths of stay.
This study has been approved by the Ethics Committee of Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine (LY2023-239-C) and approved by each participating centre. This report follows the Consolidated Standards of Reporting Trials reporting guideline for randomised studies. The findings will be shared in academic meetings and peer-reviewed academic journals.
NCT06653465.
谵妄是老年患者大手术后常见的并发症，可导致神经认知功能下降等不良后果。对乙酰氨基酚是围手术期多模式镇痛中使用最广泛的辅助药物之一。既往研究表明，它能有效减轻术后疼痛、减少阿片类药物用量并发挥抗神经炎症反应，显示出预防术后谵妄的强大潜力。因此，我们提出检验主要假设：术后静脉注射对乙酰氨基酚可降低老年患者非心脏大手术后5天内谵妄的发生率。
我们计划开展一项多中心、随机、安慰剂对照、平行组试验，纳入年龄>65岁、计划行非心脏大手术且预计全身麻醉持续至少2小时的患者。共招募1930例老年患者，按1:1比例随机分为对乙酰氨基酚组或生理盐水安慰剂组，按年龄、教育水平和试验地点分层并采用随机区组设计。手术结束开始缝合时给予对乙酰氨基酚或生理盐水，术后48小时内共给药7次。我们的主要结局是谵妄的发生率，术后第5天前每天评估2次。次要和探索性结局将包括活动时的疼痛评分、阿片类药物总用量、谵妄严重程度、重症监护病房住院时间和住院时间。
本研究已获得上海交通大学医学院附属仁济医院伦理委员会批准（LY2023-239-C），并获得各参与中心批准。本报告遵循随机研究的试验报告统一标准报告指南。研究结果将在学术会议和同行评审学术期刊上发表。
NCT06653465。
