电针预处理对老年患者术后谵妄的影响

注册号:

Registration number:

AMCTR-IPC-17000095 

注册号获得时间:

Date of releasing the registration number:

2018/3/15 16:10:04 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针预处理对老年患者术后谵妄的影响 

Public title:

Effects of preconditioning of electro-acupuncture on postoperative delirium in elderly 

研究课题的正式科学名称:

电针预处理对老年患者术后谵妄的影响 

Scientific title:

Effects of preconditioning of electro-acupuncture on postoperative delirium in elderly 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR-IOR-17012384 

申请注册联系人:

张琦 

研究负责人:

王秋筠 

Applicant:

Qi Zhang 

Study leader:

Qiujun Wang 

申请注册联系人电话:

Applicant telephone:

+86 18732199600 

研究负责人电话:

Study leader's telephone:

+86 18533112929 

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:

490082645@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

13933178001@163.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:

河北省石家庄市桥西区自强路139号 

研究负责人通讯地址:

河北省石家庄市桥西区自强路139号 

Applicant address:

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei, China 

Study leader's address:

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei, China 

申请注册联系人邮政编码:

Applicant postcode:

050051 

研究负责人邮政编码:

Study leader's postcode:

050051 

申请人所在单位:

河北医科大学第三医院 

Applicant's institution:

The Third Hospital of Hebei 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:

2016-12-01 

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:

河北医科大学第三医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Third Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-07 

研究实施负责(组长)单位:

河北医科大学第三医院 

Primary sponsor:

The Third Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市桥西区自强路139号 

Primary sponsor's address:

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei, 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):

河北

市(区县):

Country:

China

Province:

Hebei

City:

单位(医院):

河北医科大学第三医院

具体地址:

河北省石家庄市桥西区自强路139号

Institution
hospital:

The Third Hospital of Hebei Medical University

Address:

139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei, China

经费或物资来源:

河北省政府资助临床优秀人才培养和基础课题研究项目(361005) 

Source(s) of funding:

Hebei Provincial Government Funded Clinical Talents Cultivation and Basic Research Projects (361005) 

研究疾病:

腰椎间盘突出症 

Target disease:

prolapse of lumbar intervertebral disc 

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:

I期临床试验 

Study phase:

Phase I 

研究目的:

本研究拟评价电针预处理对全麻老年患者术后谵妄的影响 

Objectives of Study:

The purpose of this study is to evaluate the effects of preconditioning of electro-acupuncture on postoperative delirium in elderly under general anesthesia 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

(1)全身麻醉下接受腰后路减压植骨融合内固定术的老年腰椎间盘突出症患者,ASA分级为I或II级,(2)无脑损伤,,神经疾病及酗酒史,(3)术前无认知功能障碍,(4)无视觉和听力损伤,无明显的心肺肝肾功能异常 

Inclusion criteria

(1) Elderly patients with prolapse of lumbar intervertebral disc receiving Posterior lumbar decompression bone grafting and internal fixation under general anesthesia,American Society of Anesthesiologists' physical status classes I & II; (2) no history of traumatic brain injury, neurological diseases and alcohol abuse; (3) no cognitive dysfunction; (4) no severe vision or hearing impairment and no obvious abnormality of heart, lung, liver and kidney function. 

排除标准:

(1)手术时间超过3小时,(2)术中出血量超过800ml,(3)手术因各种原因被取消 

Exclusion criteria:

(1) Operation time is greater thsna3 hours; (2) The intraoperative blood loss is more than 800 ml; (3) The surgery was cancelled for various reasons. 

研究实施时间:

Study execute time:

From2017-10-01To 2020-03-01 

干预措施:

Interventions:

组别:

对照组

样本量:

45

Group:

Control group

Sample size:

干预措施:

标准治疗

干预措施代码:

Intervention:

standard treatment

Intervention code:

组别:

电针预处理组

样本量:

45

Group:

EA group

Sample size:

干预措施:

电针预处理

干预措施代码:

Intervention:

pretreatment of EA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北医科大学第三医院 

单位级别:

三级甲等 

Institution
hospital:

the Third Hospital of Hebei Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

认知功能

指标类型:

主要指标 

Outcome:

Cognitive function

Type:

Primary indicator 

指标中文名:

白介素-6

指标类型:

次要指标 

Outcome:

IL-6

Type:

Secondary indicator 

指标中文名:

白介素-10

指标类型:

次要指标 

Outcome:

IL-10

Type:

Secondary indicator 

指标中文名:

S100β

指标类型:

次要指标 

Outcome:

S100β

Type:

Secondary indicator 

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:

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):

由专业技术人员采用随机数字表法对纳入患者进行分组

性别:

男女均可

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

The patients were grouped by a random number table by professional technicians

Gender:

Both

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):

本课题组将于2020年9月使用ResMan 进行原始数据共享

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

Our group will use ResMan to share raw data in september 2020

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):

实验数据使用ResMan 进行管理

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

The experimental data were managed using ResMan

创建人:

Creater Name:

 2017-08-18
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