ChiCTR2500099808 版本V1.0 版本创建时间2025/03/28 16:57:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500099808 

最近更新日期：

Date of Last Refreshed on：

 2025-03-28 16:57:38 

注册时间：

Date of Registration：

 2025-03-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经颅交流电刺激对老年患者髋或膝关节置换术后谵妄发生率的影响：一项随机对照试验

Public title：

Transcranial Alternative Current Stimulation for postoperative delirium in elderly patients undergoing hip and knee replacement surgery:a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经颅交流电刺激对老年患者髋或膝关节置换术后谵妄发生率的影响：一项随机对照试验

Scientific title：

Transcranial Alternative Current Stimulation for postoperative delirium in elderly patients undergoing hip and knee replacement surgery:a randomized controlled trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

赵晶 

研究负责人：

赵晶 

Applicant：

Zhaojing 

Study leader：

Zhaojing 

申请注册联系人电话：

Applicant telephone：

 +86 189 3017 3656

研究负责人电话：

Study leader's
telephone：

+86 189 3017 3656

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zhaojing@shsmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhaojing@shsmu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

上海市徐汇区宜山路600号

研究负责人通讯地址：

上海市徐汇区宜山路600号

Applicant address：

600#, Yi-Shan Road, Shanghai, China

Study leader's address：

600#, Yi-Shan Road, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海交通大学附属第六人民医院

Applicant's institution：

Shanghai Jiaotong University Affiliated Sixth People ’s Hospital

研究负责人所在单位：

上海交通大学附属第六人民医院

Affiliation of the Leader：

Shanghai Jiaotong University Affiliated Sixth People ’s Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025-035

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

上海市第六人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Sixth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-07 00:00:00

伦理委员会联系人：

孙秀秀

Contact Name of the ethic committee：

Sunxiu xiu

伦理委员会联系地址：

上海市宜山路600号

Contact Address of the ethic committee：

600#, Yi-Shan Road, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 6436 9181

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

上海交通大学附属第六人民医院

Primary sponsor：

Shanghai Jiaotong University Affiliated Sixth People ’s Hospital

研究实施负责（组长）单位地址：

上海市宜山路600号

Primary sponsor's address：

600#, Yi-Shan Road, Shanghai, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学附属第六人民医院

具体地址：

上海市徐汇区宜山路600号

Institution
hospital：

Shanghai Jiaotong University Affiliated Sixth People ’s Hospital

Address：

600#, Yi-Shan Road, Shanghai, China

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

术后谵妄  

Target disease：

postoperative delirium

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过经颅交流电刺激预防性干预术后谵妄相关脑区，达到降低老年患者髋或膝关节置换手术后谵妄发生率的目的，为术后谵妄的预防及干预探索新的方向，改善患者术后生存质量。  

Objectives of Study：

Through transcranial AC stimulation preventive intervention of postoperative related brain area, the purpose can reduce the incidence of delusion after hip or knee replacement surgery in elderly patients, explore a new direction for postoperative prevention and intervention, and improve the postoperative quality of life of patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①年龄：≥65岁 ②美国麻醉医师学会（ASA）分级Ⅰ~Ⅲ级 ③手术类型：接受择期髋关节或膝关节置换手术的患者 ④术前认知状态：术前认知评估正常，采用蒙特利尔认知评估量表≥26分 ⑤情绪和睡眠：术前情绪和睡眠质量在可接受范围内，焦虑量表评分不超过极端值，睡眠质量指数低于临床重度失眠标准 ⑥知情同意：患者自愿参加本研究，并签署知情同意书，了解并接受所有试验过程及可能的风险

Inclusion criteria

1 Age: >= 65 years old 2 American College of Anesthesiologists (ASA) grade I~III 3 Type of surgery: patients undergoing elective hip or knee replacement surgery 4 Preoperative cognitive status: the preoperative cognitive assessment was normal, using the Montreal Cognitive Assessment Scale >= 26 5 Emotion and sleep: the preoperative mood and sleep quality are within the acceptable range, the anxiety scale score does not exceed the extreme value, and the sleep quality index is lower than the clinical standard of severe insomnia 6 Informed consent: Patients volunteered to participate in the study and signed the informed consent form to understand and accept all trial procedures and possible risks

排除标准：

①神经系统疾病：存在影响认知的神经系统疾病患者（如阿尔茨海默病、帕金森病、中风史） ②精神疾病史：既往有严重精神疾病史的患者（如重度抑郁症、精神分裂症） ③严重听觉障碍 ④服用中枢神经系统药物：正在使用镇静剂、抗抑郁药、抗精神病药物或其他中枢神经系统药物的患者 ⑤经颅电刺激禁忌症：如植入性医疗设备、癫痫病史、严重的头皮病变或皮肤感染、孕妇、严重精神障碍、重度高血压、心肺功能障碍、颅内肿瘤或其他严重脑部病变等 ⑥急性感染或全身性炎症：急性感染或炎症状态会增加术后并发症的发生，可能影响谵妄的独立评估 ⑦其他研究参与：在最近3个月内参与其他临床试验的患者，以免多重干预对研究结果产生混淆 ⑧经判断研究者为不宜参加本临床试验的其他情况

Exclusion criteria：

1 Neurological disorders: Patients with neurological disorders affecting cognition (e. g., Alzheimer's disease, Parkinson's disease, history of stroke) 2 History of mental illness: patients with a previous history of severe mental illness (e. g., major depressive disorder, schizophrenia) 3 Severe auditory impairment 4 Taking CNS drugs: Patients who are using sedatives, antidepressants, antipsychotics, or other CNS drugs 5 Contraindications to transcranial electrical stimulation: such as implantable medical equipment, history of epilepsy, severe scalp lesions or skin infections, pregnant women, severe mental disorders, severe hypertension, cardiopulmonary dysfunction, intracranial tumors or other serious brain lesions, etc 6 Acute infection or systemic inflammation: Acute infection or inflammatory state can increase the occurrence of postoperative complications and may affect the independent assessment of delusion. 7 Other study participation: Patients participating in other clinical trials in the last 3 months to avoid confounding by multiple interventions 8 Other circumstances in which the investigator is judged to be unsuitable for participate in the clinical trial

研究实施时间：

Study execute time：

从 From 2025-01-22 00:00:00至 To 2026-07-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-03-31 00:00:00 至 To 2025-09-17 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 133

Group：

Intervention Group

Sample size：

干预措施：

1.入组患者术前1天于静息状态下采用蒙特利尔认知评估量表（Montreal Cognitive Assessment Scale，MoCA）进行术前认知功能评估, 采用状态-特质焦虑问卷（State-trait anxiety inventory，STAI）和阿姆斯特丹术前焦虑与信息需求量表(Amsterdam Preoperative Anxiety and Information Scale, APAIS)进行基线焦虑评估, 彩用匹兹堡睡眠质量指数（Pittsburgh Sleep Quality ，PSQI)量表和理查兹坎贝尔睡眠问卷（Richards-Campbell Sleep Questionnaire, RCSQ）获取患者睡眠的基线数据。 2.术前一天早晨, 术前一天下午, 手术当天术前半小时给予患者电流强度2mA、频率10Hz、每次时长30分钟的交流电刺激干预。 3.术前禁食8 h，禁饮4 h。入室后开放上肢静脉通道，监测ECG、BP、SpO2和EEG。麻醉诱导：依次静脉注射舒芬太尼0.2ug/kg，丙泊酚2mg/kg，药物起效完全后进行喉罩置入，之后髋关节置换采用腰骶丛神经阻滞（0.33%罗哌卡因），膝关节置换采用股神经+股外侧皮神经阻滞（0.33%罗哌卡因）。麻醉维持：使用七氟醚进行麻醉维持，最低肺泡气有效浓度（MAC）0.8%-1%，按需求间断追加舒芬太尼镇痛。术中采用小VT通气策略VT 6～8 ml/kg，调整RR维持PETCO235～45mmHg。术中若患者血压升高幅度超过基础值的20%，排除疼痛等原因后给予尼卡地平0.4 mg注射，5 min后可重复；若患者血压降低幅度超过基础值的20%时，排除血管内容量因素后，若HR＞50次/分时，给予去氧肾上腺素40μg；若HR＜50次/分时，给予麻黄碱5 mg。若HR减慢幅度大于基础值的20%时，给予阿托品0.3～0.5 mg。若HR>100次/分，排除容量不足、血红蛋白过低、疼痛等原因后静注艾司洛尔20 mg。手术结束后停止麻醉用药，送复苏室苏醒。 按照标准麻醉复苏方案，待患者自主呼吸、肌张力与意识恢复后，生命体征平稳予以拔除喉罩，然后开始每一分钟间隔对患者进行口头讲话，直到他们的警觉性/镇静评估（OAA/S）量表上获得>2分，这一次被记录并定义为麻醉苏醒。 4.手术当天术后6小时, 术后第一天早晨和术后第一天下午给予患者电流强度2mA、频率10Hz、每次时长30分钟的交流电刺激干预。 5.谵妄评估将分别在在术后6小时、术后第一天, 第二天, 第三天的早晨和黄昏时间7个时间点节点开展，病房采用混乱评估法（Confusion Assessment Method ，CAM），ICU患者采用混乱评估法（Confusion Assessment Method for the ICU，CAM-ICU）；焦虑和睡眠质量评估分别在术后24小时、术后48小时、术后72小时和术后第7天多个时间节点进行。

干预措施代码：

Intervention：

1. The enrolled patients used the Montreal cognitive Assessment Scale (Montreal Cognitive Assessment Scale, MoCA) for preoperative cognitive function assessment using the State-Trait Anxiety Questionnaire (State-trait anxiety inventory, STAI) and the Amsterdam preoperative anxiety and information demand table (Amsterdam Preoperative Anxiety and Information Scale, APAIS) for baseline anxiety assessment performed with the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality, The PSQI) scale and the Richards Campbell Sleep Questionnaire (Richards-Campbell Sleep Questionnaire, RCSQ) to obtain baseline data on patients sleep. 2. The morning of the day before surgery was given the AC electric stimulation intervention with the current intensity of 2 mA, 10Hz and 30 minutes in the afternoon of the day of surgery. 3. preoperative fasting for 8 h and no drinking for 4 h. Upper limb venous channels were open after home entry, monitoring for ECG, BP, SpO 2 and EEG. Anesthesia induction: intravenous sufentanil 0.2 ug / kg, propofol 2mg / kg, laryngeal mask placement after complete onset of drug, then lumbosacral plexus block (0.33% ropivacaine) for hip replacement and femoral nerve + lateral femoral cutaneous nerve block (0.33% ropivacaine) for knee replacement. Anesthesia maintenance: Anesthesia maintenance with sevoflurane, minimum effective concentration of alveolar gas (MAC) 0.8% -1%, and intermittent sufentanil analgesia as required. The intraoperative small VT ventilation strategy was used for VT 6~8 ml / kg, and the RR was adjusted to maintain PETCO235~45mmHg. If the increase of blood pressure exceeds 20% of basal value, nicardipine 0.4 mg after excluding pain and repeated after 5 min; if the decrease of blood pressure exceeds 20% of basal value, 40 μ g for HR>50 and 5 mg for ephedrine. If the HR slowdown is greater than 20% of the base value, the atropine was given 0.3 to 0.5 mg. If HR>100 times / min, quietly inject esmolol 20 mg after excluding insufficient volume, low hemoglobin, pain, etc. After the operation, anesthesia was stopped and sent to the resuscitation room. Following the standard resuscitation protocol, the laryngeal mask was removed after spontaneous breathing, muscle tone and consciousness, and the patient was addressed verbally at minute intervals until their alertness / sedation assessment (OAA / S) scale, which was recorded and defined as anesthesia. 4. ACS electric stimulation intervention with current intensity 2 mA, frequency 10Hz and 30 minutes in the morning of the operation on the first day after the operation and in the afternoon of the first day after the operation. 5. False assessment will be conducted at 7 time points at 6 hours after surgery, on the morning of the third day of the first day and at dusk, respectively, The ward uses the confusion assessment method (Confusion Assessment Method, CAM), ICU patients were assessed by confusion assessment (Confusion Assessment Method for the ICU, CAM-ICU); Anxiety and sleep quality assessments were performed at multiple time nodes at 24,48,72, and day 7, respectively.

Intervention code：

组别：

对照组

样本量：

 133

Group：

Control Group

Sample size：

干预措施：

1.入组患者术前1天于静息状态下采用蒙特利尔认知评估量表（Montreal Cognitive Assessment Scale，MoCA）进行术前认知功能评估, 采用状态-特质焦虑问卷（State-trait anxiety inventory，STAI）和阿姆斯特丹术前焦虑与信息需求量表(Amsterdam Preoperative Anxiety and Information Scale, APAIS)进行基线焦虑评估, 彩用匹兹堡睡眠质量指数（Pittsburgh Sleep Quality ，PSQI)量表和理查兹坎贝尔睡眠问卷（Richards-Campbell Sleep Questionnaire, RCSQ）获取患者睡眠的基线数据。 2.术前一天早晨, 术前一天下午, 手术当天术前半小时给予患者假刺激，每次时长30分钟。 3.术前禁食8 h，禁饮4 h。入室后开放上肢静脉通道，监测ECG、BP、SpO2 和EEG。麻醉诱导：依次静脉注射舒芬太尼0.2ug/kg，丙泊酚2mg/kg，药物起效完全后进行喉罩置入，之后髋关节置换采用腰骶丛神经阻滞（0.33%罗哌卡因），膝关节置换采用股神经+股外侧皮神经阻滞（0.33%罗哌卡因）。麻醉维持：使用七氟醚进行麻醉维持，最低肺泡气有效浓度（MAC）0.8%-1%，按需求间断追加舒芬太尼镇痛。术中采用小VT通气策略VT 6～8 ml/kg，调整RR维持PETCO235～45mmHg。术中若患者血压升高幅度超过基础值的20%，排除疼痛等原因后给予尼卡地平0.4 mg注射，5 min后可重复；若患者血压降低幅度超过基础值的20%时，排除血管内容量因素后，若HR＞50次/分时，给予去氧肾上腺素40μg；若HR＜50次/分时，给予麻黄碱5 mg。若HR减慢幅度大于基础值的20%时，给予阿托品0.3～0.5 mg。若HR>100次/分，排除容量不足、血红蛋白过低、疼痛等原因后静注艾司洛尔20 mg。手术结束后停止麻醉用药，送复苏室苏醒。 按照标准麻醉复苏方案，待患者自主呼吸、肌张力与意识恢复后，生命体征平稳予以拔除喉罩，然后开始每一分钟间隔对患者进行口头讲话，直到他们的警觉性/镇静评估（OAA/S）量表上获得>2分，这一次被记录并定义为麻醉苏醒。 4.手术当天术后6小时, 术后第一天早晨和术后第一天下午给予患者假刺 激，每次时长30分钟。 5.谵妄评估将分别在在术后6小时、术后第一天, 第二天, 第三天的早晨和黄 昏时间7个时间点节点开展（病房3D-CAM、重症监护室CAM-ICU）；焦虑和睡眠质量评估分别在术后24小时、术后48小时、术后72小时和术后第7天多个时间节点进行。

干预措施代码：

Intervention：

1. The enrolled patients were assessed with the Montreal cognitive Assessment Scale at resting state 1 day before surgery (Montreal Cognitive Assessment Scale, MoCA) for preoperative cognitive function assessment using the State-Trait Anxiety Questionnaire (State-trait anxiety inventory, STAI) and the Amsterdam preoperative anxiety and information demand table (Amsterdam Preoperative Anxiety and Information Scale, APAIS) for baseline anxiety assessment performed with the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality, The PSQI) scale and the Richards Campbell Sleep Questionnaire (Richards-Campbell Sleep Questionnaire, RCSQ) to obtain baseline data on patients sleep. 2. False stimulation in the morning of the day before the afternoon of the operation on the day of operation.The second duration was 30 min. 3. preoperative fasting for 8 h and no drinking for 4 h. The upper limb venous channels were opened after home entry to monitor ECG, BP, and SpO 2 And EEG. Anesthesia induction: intravenous sufentanil 0.2 ug / kg, propofol 2mg / kg, laryngeal mask placement after complete onset of drug effect, then lumbosacral plexus block (0.33% ropivacaine) for hip replacement, and femoral nerve + lateral femoral cutaneous nerve block (0.33% ropivacaine) for knee replacement. Anesthesia maintenance: Anesthesia maintenance with sevoflurane, minimum effective concentration of alveolar gas (MAC) 0.8% -1%, and intermittent sufentanil analgesia as required. The small VT ventilation strategy was used for intraoperative VT 6~8 ml / kg, and the RR was adjusted to maintain PETCO235~45mmHg. If the increase of blood pressure exceeds 20% of basal value, nicardipine 0.4 mg after excluding pain and repeated after 5 min; if the decrease of blood pressure exceeds 20% of basal value, 40 μ g for HR>50 and 5 mg for ephedrine. If the HR slowdown is greater than 20% of the base value, the atropine was given 0.3 to 0.5 mg. If HR & gt; 100 times / min, quietly inject esmolol 20 mg after excluding insufficient volume, low hemoglobin, pain, etc. After the operation, anesthesia was stopped and sent to the resuscitation room. Following the standard resuscitation protocol, the laryngeal mask was removed after spontaneous breathing, muscle tone and consciousness, and the patient was addressed verbally at minute intervals until their alertness / sedation assessment (OAA / S) scale, which was recorded and defined as anesthesia. 4. The patients were given false thorns in the morning of 6 hours after the postoperative day and on the first day in the afternoon of the postoperative day Each time, lasting for 30 minutes. 5 False assessments will be made in the morning of 6 hours and the third day of the second day, respectively It was performed at 7 time points (ward 3D-CAM, ICU CAM-ICU); anxiety and sleep quality were assessed at 24 hours, 48 hours, 72 hours, and 7th day, respectively.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海交通大学附属第六人民医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Jiaotong University Affiliated Sixth People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

混乱评估法

指标类型：

主要指标

Outcome：

Confusion assessment method (CAM)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

阿姆斯特丹术前焦虑与信息需求量表问卷

指标类型：

次要指标

Outcome：

Amsterdam Preoperative Anxiety and Information Demand Table Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

状态-特质焦虑问卷

指标类型：

次要指标

Outcome：

State-trait anxiety inventory,STAI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量指数问卷

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality ,PSQI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

理查兹坎贝尔睡眠问卷

指标类型：

次要指标

Outcome：

Richards-Campbell Sleep Questionnaire, RCSQ

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SF-36生活质量表调查表

指标类型：

次要指标

Outcome：

SF-36 Quality of life table questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用简单随机化法，独立的统计学专业人员使用 SPSS 23.0 软件中的随机数字表法，把符合条件的患者按 1:1 的比例随机分到干预组和对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Using the simple randomization method, independent statistical professionals used the random number table method in SPSS 23.0 software to randomize eligible patients to the intervention group and the control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

双盲。 研究参与者：参与者将被告知他们将会接受经颅交流电刺激干预，但不会被告知具体是哪一种干预方式（交流电刺激干预或安慰剂）。 研究执行者：评估人员（例如，护士、医生）将不知道参与者被分配到哪个组别。

Blinding：

Double blinded. Study Participants: Participants will be informed that they will receive a transcranial AC electrical stimulation intervention, but not exactly which intervention it is given (AC electrical stimulation intervention or placebo). Study performer: The assessors (e. g., nurse, doctor) will not know to which group the participant is assigned.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-03-28 16:57:38