今天是:2019-12-13 星期五

术中不同血压调控水平对老年髋关节置换患者术后谵妄的影响
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注册号:

Registration number:

ChiCTR1900022411 

最近更新日期:

Date of Last Refreshed on:

2019-04-10 

注册时间:

Date of Registration:

2019-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

术中不同血压调控水平对老年髋关节置换患者术后谵妄的影响 

Public title:

Effects of intraoperative different blood pressure regulation on postoperative delirium in elderly patients undergoing hip repalcement 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术中不同血压调控水平对老年髋关节置换患者术后谵妄的影响 

Scientific title:

Effects of intraoperative different blood pressure regulation on postoperative delirium in elderly patients undergoing hip repalcement 

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:

徐杏梅 

研究负责人:

胡宪文 

Applicant:

Xingmei Xu 

Study leader:

Xianwen Hu 

申请注册联系人电话:

Applicant telephone:

+86 18119600183 

研究负责人电话:

Study leader's telephone:

+86 15155159719 

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:

1784158909@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

huxianwen001@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:

安徽省合肥市经开区芙蓉路678号 

研究负责人通讯地址:

安徽省合肥市经开区芙蓉路678号 

Applicant address:

678 Furong Road, Economic Development Zone, Hefei, Anhui 

Study leader's address:

678 Furong Road, Economic Development Zone, Hefei, Anhui 

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:

安徽医科大学第二附属医院 

Applicant's institution:

Second Affiliated Hospital of Anhui 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:

PJ-YX2018-048(F1) 

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:

安徽医科大学第二附属医院医学研究伦理委员会 

Name of the ethic committee:

Medical Research Ethics Committee of the Second Affiliated Hospital of Anhui Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-02 

伦理委员会联系人:

张静 

Contact Name of the ethic committee:

Jing Zhang 

伦理委员会联系地址:

安徽医科大学第二附属医院科教楼四楼 

Contact Address of the ethic committee:

Fourth Floor, the Science and Education Building, the Second Hospital of AnHui Medical University, 678 Furong Road, Economic Development Zone, Hefei, Anhui 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0551-63806098 

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:

安徽医科大学第二附属医院麻醉科 

Primary sponsor:

Department of Anesthesiology, the Second Hospital of AnHui Medical University  

研究实施负责(组长)单位地址:

安徽省合肥市经开区芙蓉路678号 

Primary sponsor's address:

678 Furong Road, Economic Development Zone, Hefei, Anhui 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

安徽省

市(区县):

合肥市

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

安徽医科大学第二附属医院

具体地址:

经开区芙蓉路678号

Institution
hospital:

the Second Hospital of AnHui Medical University

Address:

678 Furong Road, Economic Development Zone

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

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:

其它 

Study phase:

N/A 

研究目的:

研究老年髋关节置换术患者术中不同血压调控水平对术后谵妄的影响。 

Objectives of Study:

To evaluate the effect of different intraoperative blood pressure on postoperative delirium in elderly patients undergoing hip replacement. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 性别不限,年龄65-80岁; (2) ASA分级II-III级; (4) 能正确理解简易智力量表(mini-mental state examination, MMSE)的内容,术前 MMSE 评分≥23分; (6) 自愿受试并签署知情同意书者。 

Inclusion criteria

(1) No gender restriction, aged 65-80 years; (2) ASA level II-III; (3) Correctly understand the contents of the mini-mental state examination (MMSE), and the preoperative MMSE score was 23; (4) Voluntarily take the test and sign the informed consent. 

排除标准:

(1) 中枢神经系统疾病; (2) 近半年内服用精神类药物史; (3) 术中MAP值≤65mmHg、MAP≥110mmHg者; (4) 严重视觉、听觉或语言交流障碍者; (5) 肝肾功能障碍; (6) 酗酒者。 

Exclusion criteria:

(1) Central nervous system diseases; (2) With a history of taking psychiatric drugs within half a year before admission; (3) Intraoperative MAP value 65mmHg, MAP 110mmHg; (4) Severely impaired visual, auditory or verbal communication; (5) Liver or kidney dysfunction; (6) Alcoholics. 

研究实施时间:

Study execute time:

From2019-04-10To 2019-12-22 

干预措施:

Interventions:

组别:

A组

样本量:

50

Group:

group A

Sample size:

干预措施:

MAP维持于基础值水平以下10%至20%水平

干预措施代码:

Intervention:

MAP was maintained 10-20% below the baseline

Intervention code:

组别:

B组

样本量:

50

Group:

group B

Sample size:

干预措施:

MAP维持于基础值水平以下10%至基础值水平

干预措施代码:

Intervention:

MAP was maintained within a range from 10% below the baseline to the baseline

Intervention code:

组别:

C组

样本量:

50

Group:

group C

Sample size:

干预措施:

MAP维持于基础值水平至以上10%水平

干预措施代码:

Intervention:

MAP was maintained within a range from baseline to 10% above the baseline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

国家 

省(直辖市):

安徽省 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽医科大学第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

the Second Hospital of AnHui Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后谵妄

指标类型:

主要指标 

Outcome:

postoperative delirium

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中脑氧饱和度值

指标类型:

主要指标 

Outcome:

Intraoperative cerebral oxygen saturation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管活性药物应用

指标类型:

主要指标 

Outcome:

Application of vasoactive drugs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中各时间点生命体征

指标类型:

主要指标 

Outcome:

Vital signs at all time points during the operation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后疼痛评分

指标类型:

主要指标 

Outcome:

postoperative pain score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

length of postoperative hospital stay

Type:

Primary 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:

组织:

Sample Name:

No

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 80 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):

由统计软件SAS产生随机序列。

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

Random sequence generated by SAS.

盲法:

open

Blinding:

open

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

在中国临床试验注册中心共享

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

sharing in Chinese clinical trial registry

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-10
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