Clinical efficacy evaluation of electroacupuncture in the prevention and treatment of perioperative neurocognitive impairment and exploration of inflammatory factor markers

注册号:

Registration number:

ITMCTR2024000298

最近更新日期:

Date of Last Refreshed on:

2024-08-25

注册时间:

Date of Registration:

2024-08-25

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

电针防治围手术期神经认知障碍的临床疗效评价及炎症因子标志物的探究

Public title:

Clinical efficacy evaluation of electroacupuncture in the prevention and treatment of perioperative neurocognitive impairment and exploration of inflammatory factor markers

注册题目简写:

English Acronym:

研究课题的正式科学名称:

电针防治围手术期神经认知障碍的临床疗效评价及炎症因子标志物的探究

Scientific title:

Clinical efficacy evaluation of electroacupuncture in the prevention and treatment of perioperative neurocognitive impairment and exploration of inflammatory factor markers

研究课题的正式科学名称简写:

Scientific title acronym:

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:

方琴琴

研究负责人:

李璟

Applicant:

Qinqin Fang

Study leader:

Jing Li

申请注册联系人电话:

Applicant telephone:

+86 135 3586 4705

研究负责人电话:

Study leader's telephone:

+86 189 3056 8565

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:

fangqq0623@163.com

研究负责人电子邮件:

Study leader's E-mail:

1971921250@qq.com

申请单位网址(自愿提供):

Study leader's 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:

上海市虹口区甘河路110号

研究负责人通讯地址:

上海市虹口区甘河路110号

Applicant address:

110 Ganhe Road Hongkou District Shanghai

Study leader's address:

110 Ganhe Road Hongkou District Shanghai

申请注册联系人邮政编码:

Applicant postcode:

200437

研究负责人邮政编码:

Study leader's postcode:

200437

申请人所在单位:

上海中医药大学附属岳阳中西医结合医院

Applicant's institution:

Yueyang Hospital of integrated Traditional Chinese and WesternMedicine Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024-037

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee:

Ethics Committee of Yueyang Hospital of integrated Traditional Chinese and WesternMedicine Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/3/25 0:00:00

伦理委员会联系人:

殷从全

Contact Name of the ethic committee:

Congquan Yin

伦理委员会联系地址:

上海市虹口区甘河路110号

Contact Address of the ethic committee:

110 Ganhe Road Hongkou District Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

021-65161782-8122

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yyyyllwyh@163.com

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院

Primary sponsor:

Yueyang Hospital of integrated Traditional Chinese and WesternMedicine Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号

Primary sponsor's address:

110 Ganhe Road Hongkou District Shanghai

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

市(区县):

市辖区

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of integrated Traditional Chinese and WesternMedicine Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road Hongkou District Shanghai

经费或物资来源:

上海市科学技术委员会

Source(s) of funding:

Shanghai Municipal Commission of Science and Technology

研究疾病:

围手术期认知障碍

研究疾病代码:

Target disease:

Perioperative Neurocognitive Disorder

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

本研究立足临床,通过进行前瞻性、区组随机、对照研究,旨在为电针应用于防治老年人髋关节手术围手术期神经认知障碍提供循证依据,明确电针治疗预防PND的临床疗效。并揭示电针在调节炎症因子水平的潜在效应机制,寻找可用于前期识别和预测围手术期认知功能预后的敏感标志物。

Objectives of Study:

This study is based on clinical practice and aims to provide evidence-based evidence for the application of electroacupuncture in the prevention and treatment of perioperative neurocognitive impairment in elderly patients undergoing hip joint surgery through prospective randomized and controlled studies and to clarify the clinical efficacy of electroacupuncture in preventing PND. And reveal the potential mechanism of electroacupuncture in regulating inflammatory cytokine levels and search for sensitive biomarkers that can be used for early identification and prediction of perioperative cognitive function prognosis.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

None

纳入标准:

(1)美国麻醉医师协会(ASA)分级I~III级; (2)年龄≥65周岁且≤95周岁,性别不限; (3)髋部骨折患者:①股骨颈骨折,择期行全麻下关节置换或内固定手术;②股骨粗隆间骨折,择期行全麻下髓内钉内固定手术; (4)理解、同意参加本研究并签署知情同意书。

Inclusion criteria

(1) The American Society of Anesthesiologists (ASA) grades I to III; (2) Age ≥ 65 years old and ≤ 95 years old regardless of gender; (3) Hip fracture patients: ① Femoral neck fracture elective joint replacement or internal fixation surgery under general anesthesia; ② Femoral intertrochanteric fracture scheduled for intramedullary nail fixation surgery under general anesthesia; (4) Understand and agree to participate in this study and sign an informed consent form.

排除标准:

(1)严重的心、肝、 肾功能不全; (2)有创伤性脑损伤、精神系统疾病、药物滥用史或酗酒史; (3)配有起搏器或其他电刺激装置; (4)无法与医生有效沟通和合作完成认知功能测试。

Exclusion criteria:

(1) Severe heart liver and kidney dysfunction; (2) Has a history of traumatic brain injury mental illness drug abuse or alcoholism; (3) Equipped with a pacemaker or other electrical stimulation device; (4) ) Unable to effectively communicate and collaborate with doctors to complete cognitive function tests.

研究实施时间:

Study execute time:

From 2023-12-01

To      2026-11-30

征募观察对象时间:

Recruiting time:

From 2024-03-30

To      2026-05-30

干预措施:

Interventions:

组别:

试验组

样本量:

90

Group:

Experimental group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

Electroacupuncture

Intervention code:

组别:

对照组

样本量:

90

Group:

Control group

Sample size:

干预措施:

常规护理

干预措施代码:

Intervention:

Routine care

Intervention code:

样本总量 Total sample size : 180

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海市

市(区县):

市辖区

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三甲

Institution/hospital:

Yueyang Hospital of integrated Traditional Chinese and WesternMedicine Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

同型半胱氨酸

指标类型:

次要指标

Outcome:

homocysteine

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标

Outcome:

C-reactive protein

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁症筛查量表

指标类型:

次要指标

Outcome:

Patient Health Questionnaire-9

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天,并于术后第1、3、6个月随访

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

意识模糊评估法

指标类型:

次要指标

Outcome:

Confusion assessment method

Type:

Secondary indicator

测量时间点:

术后第1、3、7天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

数字广度测验

指标类型:

次要指标

Outcome:

Digital Span Test

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天,并于术后第1、3、6个月随访

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易智力状态检查量表

指标类型:

主要指标

Outcome:

Mini-mental State Examination

Type:

Primary indicator

测量时间点:

术后第7天

测量方法:

Measure time point of outcome:

On the 7th day after surgery

Measure method:

指标中文名:

神经元特异性烯醇化酶

指标类型:

次要指标

Outcome:

neuron specific enolase

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清炎症因子(IL-1β、2、4、5、6、8、10、TNF-α)

指标类型:

次要指标

Outcome:

Serum inflammatory factors

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

广泛性焦虑障碍量表

指标类型:

次要指标

Outcome:

GeneralizedAnxietyDisorder

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天,并于术后第1、3、6个月随访

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易智力状态检查量表

指标类型:

次要指标

Outcome:

Mini-mental State Examination

Type:

Secondary indicator

测量时间点:

术后第1、3天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分法

指标类型:

次要指标

Outcome:

Visual Analogue Scale

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天,并于术后第1、3、6个月随访

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中枢神经特异蛋白

指标类型:

次要指标

Outcome:

central nervous specific protein

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超氧化物歧化酶

指标类型:

次要指标

Outcome:

Superoxide Dismutase

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天

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量表

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Quality Index

Type:

Secondary indicator

测量时间点:

术前、术后第1、3、7天,并于术后第1、3、6个月随访

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 65
Min age years
最大 95
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究为区组随机化、平行对照设计,共分为2组:治疗组(电针组)、对照组(基础治疗组),区组长度为6,通过SPSS软件生成随机数表,将完成知情同意书签署的受试者按照1:1的比例随机分配至上述两组。

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

This study is a randomized parallel controlled design with two groups: the treatment group (electroacupuncture group) and the control group (basic treatment group). The length of each group is 6. A random number table was generated using SPSS software and participants who completed the signing of informed consent forms were randomly assigned to the two groups in a 1:1 ratio.

盲法:

本次研究考虑到电针治疗操作的特殊性,对纳入的受试者、针灸医师不设盲,对外科医生、麻醉医师、结局评价人员及统计分析人员实施盲法。

Blinding:

In this study considering the particularity of electroacupuncture treatment there is no blindness for the included subjects and acupuncture and moxibustion and the blind method is implemented for surgeons anesthesiologists outcome evaluators and statistical analysts.

是否共享原始数据:

IPD sharing:

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/uc/index.aspx”

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

ResMan Research Manager"http://www.medresman.org.cn/uc/index.aspx"

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:

1.病例记录表,2.电子采集和管理系统

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

1.Case Record Form(CRF); 2.Electronic Data Capture(EDC)

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above