ChiCTR2400081758 版本V1.0 版本创建时间2024/03/11 15:26:59 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：

 ChiCTR2400081758 

最近更新日期：

Date of Last Refreshed on：

 2024-03-11 15:26:35 

注册时间：

Date of Registration：

 2024-03-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

耳穴揿针联合经皮穴位电刺激对老年患者术后认知功能和唾液皮质醇的影响

Public title：

Auricular acupuncture combined with percutaneous acupoint electrical stimulation for elderly patients Effects of postoperative cognitive function and salivary cortisol

注册题目简写：

English Acronym：

研究课题的正式科学名称：

耳穴揿针联合经皮穴位电刺激对老年患者术后认知功能和唾液皮质醇的影响

Scientific title：

Auricular acupuncture combined with percutaneous acupoint electrical stimulation for elderly patients Effects of postoperative cognitive function and salivary cortisol

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：

马艺宸 

研究负责人：

刘艳秋 

Applicant：

Ma Yichen 

Study leader：

Liu Yanqiu 

申请注册联系人电话：

Applicant telephone：

 +86 139 8549 9547

研究负责人电话：

Study leader's
telephone：

+86 181 9861 8386

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：

 907161872@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1150725102@qq.com

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：

贵州省贵阳市南明区解放西路91号

研究负责人通讯地址：

贵州省贵阳市南明区解放西路91号

Applicant address：

91 Jiefang Road West, Nanming District, Guiyang, Guizhou

Study leader's address：

91 Jiefang Road West, Nanming District, Guiyang, Guizhou

申请注册联系人邮政编码：

Applicant postcode：

 550002

研究负责人邮政编码：

Study leader's postcode：

 550002

申请人所在单位：

贵阳市第四人民医院

Applicant's institution：

Guiyang Fourth People's Hospital

研究负责人所在单位：

贵阳市第四人民医院

Affiliation of the Leader：

Guiyang Fourth 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：

 [2023]伦审第(023)号

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：

贵阳市第四人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Guiyang Fourth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-06-15 00:00:00

伦理委员会联系人：

龙胜利

Contact Name of the ethic committee：

Long shengli

伦理委员会联系地址：

贵州省贵阳市南明区解放西路91号

Contact Address of the ethic committee：

91 Jiefang Xi Lu, Nanming District, Guiyang City, Guizhou Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 851 8596 7482

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：

贵阳市第四人民医院

Primary sponsor：

Guiyang Fourth People's Hospital

研究实施负责（组长）单位地址：

贵州省贵阳市南明区解放西路91号

Primary sponsor's address：

91 Jiefang Xi Lu, Nanming District, Guiyang City, Guizhou Province, 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)：

贵州

市(区县)：

贵阳

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

贵阳市第四人民医院

具体地址：

贵州省贵阳市南明区解放西路91号

Institution
hospital：

Guiyang Fourth People's Hospita

Address：

91 Jiefang Xi Lu, Nanming District, Guiyang City, Guizhou Province, China

经费或物资来源：

研究者及医院科室资助

Source(s) of funding：

Investigator and hospital departmental funding

研究疾病：

术后认知功能障碍  

Target disease：

Postoperative cognitive dysfunction

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：

1、揭示耳穴揿针联合经皮穴位电刺激对老年患者术后认知功能的影响及其可能机制； 2、为临床预防老年患者POCD提供新的策略和方案。  

Objectives of Study：

1. To reveal the effect of ear acupuncture combined with percutaneous acupoint electrical stimulation on postoperative cognitive function in elderly patients and its possible mechanism; 2. To provide new strategies and programs for clinical prevention of POCD in elderly 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65～80岁，行择期行单侧全髋关节置换术，男女不限；②腰硬联合麻醉；③精神状态良好，沟通无障碍并可以完成测试MMSE量表，且术前MMSE评分在正常范围；④患者自愿且家属同意参加本试验,并签署知情同意书。

Inclusion criteria

① Patients aged 65-80 years old and eligible for unilateral total hip arthroplasty, male or female; ② combined epidural anesthesia; ③ Good mental state, barrier-free communication, able to complete the test MMSE scale, and preoperative MMSE score in the normal range; ④The patient voluntarily and his family members agreed to participate in the study, and signed the informed conse

排除标准：

①过敏体质，既往对胶布过敏者；②外耳皮肤不宜贴敷揿针者，如外耳有破损、湿疹、溃疡、冻疮等；③术前有精神病史者；④存在沟通障碍、认知障碍或既往脑功能受损者；⑤有长期服用镇静药、三环类抗抑郁药物或长期吸毒史者；⑥有恶性肿瘤病史或严重消耗性疾病；⑦既往有冠状动脉旁路移植手术史。

Exclusion criteria：

① Allergic constitution, allergic to tape in the past; ② The skin of the outer ear should not be affixed with the needle, such as the outer ear has damage, eczema, ulcers, chilblain, etc.; ③ Patients with a history of mental illness before surgery; ④ Communication disorders, cognitive impairment or previous brain function impairment; ⑤ Long-term use of sedatives, tricyclic antidepressants or long-term drug use history; ⑥A history of malignant tumors or severe wasting diseases; ⑦History of coronary artery bypass transplantation.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-01 00:00:00 至 To 2024-09-30 00:00:00

干预措施：

Interventions：

组别：

对照组（A 组，30例）

样本量：

 30

Group：

Group A

Sample size：

干预措施：

术前严格予以禁食8小时、禁水4小时，均不使用术前用药。术前一天（T0时点）由同一名不参与分组的研究者对患者进行MMSE评分，采集唾液（采集前漱口后用注射器抽吸口底部混合性唾液2ml）。给予双侧耳穴神门、肾上腺贴敷外观相同不含针体的假贴片，不予按摩刺激；麻醉完成后在双侧百会穴和双侧内关穴安置经皮穴位电刺激电极片，连接神经刺激仪，不予按摩刺激；其他步骤同治疗组。术后24h（T5时点）、72h（T6时点）仍由同一名不参与分组的研究者对患者随访，采集唾液，并进行MMSE评分。

干预措施代码：

Intervention：

Strict fasting for 8 hours and water prohibition for 4 hours before surgery were not used. One day before surgery (T0 hour), the same researcher who did not participate in the group assessed the patients' MMSE scores, and collected saliva (2ml of mixed saliva at the bottom of the mouth was aspirated with a syringe after gargling before collection). The fake patch with the same appearance without needle body was applied to both auricular points and adrenal gland without massage stimulation. After the anesthesia was completed, the percutaneous acupoint electrical stimulation electrodes were placed at both Baihui and Neiguan points, and the neurostimulator was connected without massage stimulation. The other steps are the same as the treatment group. Patients were followed up 24h (T5 time point) and 72h (T6 time point) by the same investigator who did not participate in the group, saliva was collected, and MMSE score was performed.

Intervention code：

组别：

治疗组（B 组，30例）

样本量：

 30

Group：

Group B

Sample size：

干预措施：

术前严格予以禁食8小时、禁水4小时，均不使用术前用药。术前一天（T0时点）由同一名不参与分组的研究者对患者进行MMSE评分，采集唾液（采集前漱口后用注射器抽吸口底部混合性唾液2ml）。给予双侧耳穴神门、肾上腺揿针（型号：0.2 mm×1.5mm，苏州针灸用品有限公司）贴敷，麻醉前每个穴位按摩3次，每次5 min（双侧同时），按压力度以患者有胀、酸感或微感刺痛为度，耳穴揿针干预30min后（T2时点）按预定方案进行麻醉和手术；麻醉完成后在双侧百会穴和双侧内关穴安置经皮穴位电刺激电极片，手术开始（手术切皮，T3时点）给予穴位神经刺激仪（SD-Ⅱ型电子诊疗仪，华佗牌）刺激，频率2/200 Hz，疏密波，刺激强度以患者能耐受的最大刺激强度为准，直至手术结束（T4时点）。术后24h（T5时点）、72h（T6时点）仍由同一名不参与分组的研究者对患者随访，采集唾液，并进行MMSE评分。

干预措施代码：

Intervention：

Strict fasting for 8 hours and water prohibition for 4 hours before surgery were not used. One day before surgery (T0 hour), the same researcher who did not participate in the group assessed the patients' MMSE scores, and collected saliva (2ml of mixed saliva at the bottom of the mouth was aspirated with a syringe after gargling before collection). Give both auricular points Shenmen, adrenal press needle (Model: 0.2 mm×1.5mm, Suzhou Acupuncture Supplies Co., LTD.), each acupoint massage 3 times before anesthesia, 5 minutes each time (both sides at the same time), the pressure intensity of the patient's distension, acid or slight tingling was the degree, after 30 minutes of ear acupuncture intervention (T2 time point), anesthesia and operation were performed according to the scheduled plan; After anesthesia was completed, percutaneous acupoint electrical stimulation electrodes were placed at bilateral Baihui and bilateral Neiguan points. Acupuncture nerve stimulator (SD-II type electronic diagnostic instrument, Huatuopai) was administered at the beginning of the operation (surgical incision, T3 time point) with a frequency of 2/200 Hz and a density wave. The stimulation intensity was subject to the maximum stimulation intensity tolerated by the patient. Until the end of surgery (T4 time point). Patients were followed up 24h (T5 time point) and 72h (T6 time point) by the same investigator who did not participate in the group, saliva was collected, and MMSE score was performed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 贵阳 

Country：

China

Province：

guizhou

City：

Guiyang

单位(医院)：

 贵阳市第四人民医院 

单位级别：

 三甲 

Institution
hospital：

Guiyang Fourth People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

唾液皮质醇水平

指标类型：

主要指标

Outcome：

Salivary cortisol level

Type：

Primary indicator

测量时间点：

术前一天（T0）；术后24h（T5）；术后72h（T6）

测量方法：

采集前漱口后用注射器抽吸口底部混合性唾液2ml

Measure time point of outcome：

One day before surgery (T0); Postoperative 24 hours (T5); 72 hours post surgery (T6)

Measure method：

指标中文名：

认知功能评分量表

指标类型：

主要指标

Outcome：

MMSE

Type：

Primary indicator

测量时间点：

术前一天（T0）；术后24h（T5）；术后72h（T6）

测量方法：

MMSE评分表：MMSE评分，得分降低值大于术前2分以上，即认为发生了POCD

Measure time point of outcome：

One day before surgery (T0); Postoperative 24 hours (T5); 72 hours post surgery (T6)

Measure method：

MMSE score table: If the MMSE score decreases by more than 2 points before surgery, it is considered that POCD has occurred

指标中文名：

生命体征

指标类型：

次要指标

Outcome：

Vital sign

Type：

Secondary indicator

测量时间点：

患者入室时T1；耳穴揿针干预30min后（T2）；给予穴位神经刺激仪（SD-Ⅱ型电子诊疗仪，华佗牌）刺激，频率2/200 Hz，疏密波，刺激强度以患者能耐受的最大刺激强度为准，直至手术结束（T4）手术开始（手术切皮，T3）

测量方法：

测量无创血压（BP）、心率（HR）、氧饱和度(SPO2)

Measure time point of outcome：

T1 when the patient enters the room; 30 minutes after ear acupuncture intervention (T2); Provide acupoint nerve stimulator (SD-II electronic diagnostic and therapeutic device, Huatuo brand) with a frequency of 2/200 Hz, density wave, and stimulation intensity based on the maximum stimulation intensity that the patient can tolerate, until the end of surgery (T4) and the start of surgery (surgical skin cutting, T3)

Measure method：

Measure non-invasive blood pressure (BP), heart rate (HR), and oxygen saturation (SPO2)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

唾液

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

纸质量表

组织：

Sample Name：

Paper scale

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 80 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）：

患者手术排程后，分配序列是通过使用编号的、不透明的密封信封，信封里装着实验组和对照组的信息。一名没有参与研究的护士挑选将分配给研究对象的信封，并准备了实验用物，分配过程结果产生了分组，每组纳入30名受试者。

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

After patients are scheduled for surgery, the assignment sequence is done by using numbered, opaque sealed envelopes containing information about the experimental and control groups. A nurse who was not involved in the study selected the envelopes to be assigned to the study subjects and prepared the experiment materials, and the assignment process resulted in subgroups of 30 subjects each.

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：

未说明

Blinding：

Not stated

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

是Yes

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）：

ResMan 临床试验公共管理平台, http://www.medresman.org.cn

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

www.medresman.org.cn

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：

数据将由调查人员收集在纸上，并转录到电子数据库中。 数据的访问将仅限于调查人员和统计学家。

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

Data will be collected on paper by investigators and transcribed into an electronic database. Access to data will be limited to investigators and statistician.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-03-11 15:26:35