不同时刻与不同时长经皮穴位电刺激对老年患者术后谵妄的影响

注册号:

Registration number:

AMCTR-IOR-17000085 

注册号获得时间:

Date of releasing the registration number:

2018/3/15 18:56:13 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

不同时刻与不同时长经皮穴位电刺激对老年患者术后谵妄的影响 

Public title:

The effect of differernt time different lenght transcutaneous acupoint electrial stumulationg on olders with postoperative delirium 

研究课题的正式科学名称:

不同时刻与不同时长经皮穴位电刺激对老年患者术后谵妄的影响 

Scientific title:

The effect of differernt time different lenght transcutaneous acupoint electrial stumulationg on olders with postoperative delirium 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR-INR-17012297 

申请注册联系人:

丁玲玲 

研究负责人:

丁玲玲 

Applicant:

DING Lingling 

Study leader:

DING Lingling 

申请注册联系人电话:

Applicant telephone:

+86 18601359708 

研究负责人电话:

Study leader's telephone:

+86 18601359708 

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:

dinglingling301@126.com 

研究负责人电子邮件:

Study leader's E-mail:

dinglingling301@126.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:

北京东城区美术馆后街23号,北京中医医院 

研究负责人通讯地址:

北京东城区美术馆后街23号,北京中医医院 

Applicant address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

Study leader's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, 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:

100010 

申请人所在单位:

首都医科大学附属北京中医医院 

Applicant's institution:

Beijing hospital of tranditional chinese medline,Capital Medical University 

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:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

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:

首都医科大学附属北京中医医院伦理委员会 

Name of the ethic committee:

Ethics Committee ,Beijing Hospital of Traditional Chinese Medline ,Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-07-18 

研究实施负责(组长)单位:

首都医科大学附属北京中医医院 

Primary sponsor:

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University 

研究实施负责(组长)单位地址:

北京东城区美术馆后街23号 

Primary sponsor's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

首都医科大学 

Source(s) of funding:

Capital Medlical University 

研究疾病:

谵妄 

Target disease:

delirium 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

1.探讨经皮穴位电刺激对老年腹部手术后谵妄发生的影响 2.比较不同时期经皮穴位电刺激对老年患者术后谵妄的影响 3.对可能的机制进行分析,为临床工作提供依据 

Objectives of Study:

1. To investigate the effect of transcutaneous electrical acupoint stimulation on delirium postoperative in the elders; 2. To compare the effect of transcutaneous electrical acupoint stimulation at different stages on postoperative delirium in elders; 3. Analysis ofpossible mechanisms, provide the basis for clinical work. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

拟全身麻醉下行腹部或骨科手术,预估手术时间>3h,年龄>65岁病人,美国麻醉医师协会(ASA)分级 I~III级,BMI:18-24.9kg/m2(根据国际成人超重和肥胖症预防与控制指南),简明精神检查量表(MMSE)评分>25。患者本人能够做正常交流,包括语言能力正常,书写能力正常,视力正常,听力正常(可佩戴助听器)愿意接受穴位刺激麻醉。 

Inclusion criteria

1. Patient to be planned to accept abdominal or orthopedics operation by general anesthesia, estimated the operation time >3h; 2. aged >65 years old; 3. American Society of anesthesiologists (ASA) grade I~III, BMI 18-24.9kg/m2 (according to the international adult overweight and obesity prevention and control guidelines); 4. MMSE score >25; 5. normal communication, including normal language ability, writing ability, normal vision, hearing (can wear hearing aids) willing to accept acupuncture anesthesia. 

排除标准:

不符合上述标准,不愿接受经皮穴位电刺激,不能配合完成调查问卷者。 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2017-01-01To 2018-12-31 

干预措施:

Interventions:

组别:

Group A

样本量:

30

Group:

Group A

Sample size:

干预措施:

术前经皮穴位电刺激

干预措施代码:

Intervention:

transcutaneous electrical acupoint stimulation before operation

Intervention code:

组别:

Group B

样本量:

30

Group:

Group B

Sample size:

干预措施:

术中经皮穴位电刺激

干预措施代码:

Intervention:

transcutaneous electrical acupoint stimulation during operation

Intervention code:

组别:

Group C

样本量:

30

Group:

Group C

Sample size:

干预措施:

对照

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

首都医科大学附属北京中医医院 

单位级别:

三甲 

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine,Capital Medline University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

美国精神疾病诊断标准第4版(DSM-IV)

指标类型:

主要指标 

Outcome:

Diagnostic criteria for mental disorders in the United States, Fourth Edition (DSM-IV)

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 100 years

随机方法(请说明由何人用什么方法产生随机序列):

医院数据中心人员采用基于网络的中央随机系统(Interactive Web Respond System,IWRS)进行随机。随机号以电子邮件通知研究者。

性别:

男性

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

The hospital data center personnel were using Interactive Web Respond System to randomize. The random number is notified to the researcher by e-mail.

Gender:

Male

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

病历记录表

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

CRF

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

数据采集和管理由病例记录表进行

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Data collection and management is carried out by Case Record Form

创建人:

Creater Name:

 2017-08-09
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