Department of Anaesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Institute of Anaesthesiology, Soochow University, Suzhou, Jiangsu, China.
BMJ Open. 2024 Nov 1;14(10):e083312. doi: 10.1136/bmjopen-2023-083312.
INTRODUCTION: Elderly patients are at a high risk of postoperative delirium (POD), leading to increased postoperative morbidity and mortality. The use of dexmedetomidine and depth of anaesthesia may influence POD. This study aims to determine the effects of dexmedetomidine infusion versus normal saline placebo during light versus deep anaesthesia on POD among elderly patients undergoing major non-cardiac surgery. METHODS AND ANALYSIS: This prospective, multicentre, randomised, controlled, factorial trial will be conducted at three tertiary hospitals in Jiangsu, China. We will recruit a total of 420 patients who are at least 60 years old and undergoing major non-cardiac surgery (thoracic, abdominal, urology, orthopaedic and spine surgery) under general anaesthesia. Patients will be randomised (1:1:1:1) to receive one of four anaesthesia regimens: (1) dexmedetomidine and light anaesthesia, (2) dexmedetomidine and deep anaesthesia, (3) placebo and light anaesthesia or (4) placebo and deep anaesthesia. Dexmedetomidine will be infused at 0.5 µg/kg/h throughout surgery, and intraoperative bispectral index target will be 55 for light anaesthesia and 40 for deep anaesthesia. The primary outcome is the occurrence of POD during the first 7 days postoperatively or until hospital discharge, assessed using the 3-min Confusion Assessment Method two times per day. The secondary outcomes include days with POD, type of POD, pain scores at rest and on movement at 24 and 48 hours postoperatively, patient-controlled intravenous fentanyl consumption during 0-24 and 24-48 hours postoperatively, hypotension, bradycardia, postoperative nausea and vomiting, non-delirium complications, length of postoperative hospital stay, 30-day cognitive function and 30-day mortality. Data will be analysed on a modified intention-to-treat basis. ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University and each participating centre. The trial results will be published in a peer-reviewed journal. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300073271).
简介：老年患者术后谵妄（POD）的风险较高，导致术后发病率和死亡率增加。右美托咪定和麻醉深度可能会影响 POD。本研究旨在确定在轻度与深度麻醉下使用右美托咪定输注与生理盐水安慰剂对接受非心脏大手术的老年患者 POD 的影响。
方法和分析：这是一项在中国江苏三家三级医院进行的前瞻性、多中心、随机、对照、析因试验。我们将招募总共 420 名年龄至少 60 岁且接受全身麻醉下的非心脏大手术（胸科、腹部、泌尿科、骨科和脊柱手术）的患者。患者将按照 1:1:1:1 的比例随机分配到以下四种麻醉方案之一：（1）右美托咪定和轻度麻醉，（2）右美托咪定和深度麻醉，（3）安慰剂和轻度麻醉或（4）安慰剂和深度麻醉。右美托咪定将在整个手术过程中以 0.5μg/kg/h 的速度输注，术中双频谱指数目标值为 55 用于轻度麻醉，40 用于深度麻醉。主要结局是术后第 1 天至第 7 天（或直至出院）期间发生 POD，使用每天两次的 3 分钟意识混乱评估法进行评估。次要结局包括 POD 天数、POD 类型、术后 24 小时和 48 小时的静息和运动时疼痛评分、术后 0 至 24 小时和 24 至 48 小时的患者自控静脉芬太尼消耗量、低血压、心动过缓、术后恶心和呕吐、非谵妄并发症、术后住院时间、术后 30 天认知功能和 30 天死亡率。数据将按照修改后的意向治疗进行分析。
伦理和传播：该试验已获得苏州大学第一附属医院和每个参与中心的伦理委员会批准。试验结果将发表在同行评议的期刊上。
试验注册：中国临床试验注册中心（ChiCTR2300073271）。
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