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经颅直流电刺激对老年髋部骨折手术患者术后谵妄的影响:一项随机对照试验的研究方案

Effect of transcranial direct current stimulation on postoperative delirium in elderly patients undergoing hip fracture surgery: study protocol for a randomized controlled trial.

作者信息

Xue Li-Chao, Ji Hai-Jie, Fan Sha-Sha, Niu Qing, Zhang Jun-Yan, Fang Ai-Li, Wang Ping-Zhi, Tian Shou-Yuan, Zheng Hua

机构信息

Department of Anesthesiology, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan, China.

Department of Central Laboratory, Shanxi Province Academy of Traditional Chinese Medicine & Shanxi Traditional Chinese Medical Hospital, Taiyuan, China.

出版信息

Front Med (Lausanne). 2025 May 15;12:1558376. doi: 10.3389/fmed.2025.1558376. eCollection 2025.

Abstract

OBJECTIVE

To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing the incidence of postoperative delirium (POD) in elderly patients undergoing hip fracture surgery.

METHODS AND ANALYSIS

This single-center, double-blind, randomized controlled trial will enroll 160 participants aged 65 years and older, scheduled for elective hip surgery under spinal anesthesia. Participants will be randomly assigned to either the active-tDCS group or the sham-tDCS group. The active-tDCS group will receive two sessions: one pre-surgery and one post-surgery, with electrodes positioned over the left dorsolateral prefrontal cortex and the right supraorbital area. Each session includes 15-second ramp-up phase at the start, 20 min simulation with 2 mA current and 15-second ramp-down phase at the end. The sham-tDCS group will receive two sham procedures with no actual current delivered. Functional brain activity will be monitored before and after each session or sham procedure to assess changes in cortical activation and connectivity using functional near-infrared spectroscopy (fNIRS). The primary outcome measure will be the incidence of POD, assessed using the 3-Min Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.

TRIAL REGISTRATION

The trial was registered at ClinicalTrials.gov (NCT06678529) on Oct 22, 2024.

摘要

目的

评估经颅直流电刺激(tDCS)在降低老年髋部骨折手术患者术后谵妄(POD)发生率方面的疗效。

方法与分析

本单中心、双盲、随机对照试验将纳入160名65岁及以上计划在脊髓麻醉下进行择期髋关节手术的参与者。参与者将被随机分配到主动tDCS组或假tDCS组。主动tDCS组将接受两次治疗:一次术前治疗和一次术后治疗,电极置于左侧背外侧前额叶皮质和右侧眶上区域。每次治疗开始时包括15秒的电流上升阶段,20分钟2毫安电流模拟,结束时为15秒的电流下降阶段。假tDCS组将接受两次无实际电流输出的假治疗。每次治疗或假治疗前后将监测脑功能活动,使用功能近红外光谱(fNIRS)评估皮质激活和连接性的变化。主要结局指标将是POD的发生率,采用用于混乱评估方法的3分钟诊断访谈(3D-CAM)进行评估。次要结局包括谵妄严重程度、术后疼痛、焦虑、抑郁、认知功能和睡眠质量。

试验注册

该试验于2024年10月22日在ClinicalTrials.gov(NCT06678529)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f99/12119631/e60318ca292e/fmed-12-1558376-g0001.jpg

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