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Effect of dexmedetomidine on the perioperative circulation and postoperative cognitive function of elderly patients with hypertension
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注册号:

Registration number:

ChiCTR-IPR-16009156 

最近更新日期:

Date of Last Refreshed on:

2017-11-04 

注册时间:

Date of Registration:

2016-09-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

右美托咪定对老年高血压患者围术期循环及术后认知功能的影响 

Public title:

Effect of dexmedetomidine on the perioperative circulation and postoperative cognitive function of elderly patients with hypertension 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

右美托咪定对老年高血压患者围术期循环及术后认知功能的影响 

Scientific title:

Effect of dexmedetomidine on the perioperative circulation and postoperative cognitive function of elderly patients with hypertension 

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:

杜雪江 

研究负责人:

米卫东 

Applicant:

Xuejiang Du 

Study leader:

Weidong Mi 

申请注册联系人电话:

Applicant telephone:

+86 13847110865 

研究负责人电话:

Study leader's telephone:

+86 13381082966 

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:

xuejiangdu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wwdd1962@aliyun.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:

内蒙古呼和浩特回民区通道北街1号 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

1 Tongdao Street North, Huimin District, Huhhot, Inner Mongolia, China 

Study leader's address:

28 Fuxing Road, Haidian district, Beijing  

申请注册联系人邮政编码:

Applicant postcode:

010050 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

内蒙古医科大学第一附属医院 

Applicant's institution:

First Affiliated Hospital of Inner Mongolia 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:

2017010 

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:

内蒙古医科大学附属医院伦理委员会 

Name of the ethic committee:

Ethic xommittee of the Affiliate Hospital of Inner Mongoia Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-16 

伦理委员会联系人:

张春燕 

Contact Name of the ethic committee:

Chunyan Zhang 

伦理委员会联系地址:

内蒙古呼和浩特市新华大街 

Contact Address of the ethic committee:

Xin Hua street of Hohhot in Inner Mongolia 

伦理委员会联系人电话:

Contact phone of the ethic committee:

0471-3451027 

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:

内蒙古医科大学第一附属医院 麻醉科 

Primary sponsor:

Department of Anesthesiology, First Affiliated Hospital of Inner Mongolia medical university 

研究实施负责(组长)单位地址:

内蒙古呼和浩特回民区通道北街1号 

Primary sponsor's address:

1 Tongdao Street North, Huimin District, Huhhot, Inner Mongolia, 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):

内蒙古自治区

市(区县):

Country:

China

Province:

Inner Mongolia Autonomous Region

City:

单位(医院):

内蒙古医科大学第一附属医院

具体地址:

内蒙古呼和浩特回民区通道北街1号

Institution
hospital:

First Affiliated Hospital of Inner Mongolia medical university

Address:

1 Tongdao Street North, Huimin District, Huhhot, Inner Mongolia, China

经费或物资来源:

内蒙古医科大学第一附属医院 麻醉科 

Source(s) of funding:

Department of Anesthesiology, First Affiliated Hospital of Inner Mongolia medical university 

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:

上市后药物 

Study phase:

研究目的:

研究探讨影响血浆浓度右美托咪定对于围手术期循环和高血压的老年患者术后认知功能的影响 

Objectives of Study:

investigate the effect of dexmedetomidine on the perioperative circulation and postoperative cognitive function of elderly patients with hypertension 

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)主题,年龄在60到65岁,被诊断为原发性高血压一年或更长时间(BP≥140/90),ASA :II ~ III级,准备行择期胃肠手术; 2)患者体重45~75公斤,身体质量指数(BMI)19 kg / m2和24 kg / m2之间; 3)受试者的评估依据病史,体格检查、实验室检查,没有困难插管的迹象,没有明显的精神障碍; 4)正常的认知功能 MMSE 评分 > 27 ; 5)正常的ST段术前心电图(ECG)。 

Inclusion criteria

1. Subjects aged between 60 to 65 years old, diagnosed with primary hypertension for one year or longer (BP≥140/90), American Society of Anaesthesiologists (ASA) grade II or III, ready for elective gastrointestinal surgery; 2. Body weight between 45kg and 75kg, body mass index (BMI) between 19 kg/m2 and 24 kg/m2; 3. The health conditions of the subjects evaluated to be generally well according the medical history, physical examination, laboratory tests. No signs of difficult intubation. No obvious mental disorders; 4. Normal cognitive function, MMSE score > 27 points; 5. Normal ST segment in preoperative electrocardiogram (ECG). 

排除标准:

1.明显心律失常,房室传导阻滞,肝功能障碍,肾功能障碍,肺部疾病,内分泌疾病,其他疾病或能干扰实验结果的病理状态; 2.严重的听觉、视觉障碍,或是其他沟通障碍的原因; 3.有服用镇静剂、抗失眠药物及抗抑郁药的病史,; 4.脑梗死的历史,其他中枢神经系统疾病、器质性脑疾病或精神疾病; 5.嗜酒或药物成瘾; 6.对研究药物过敏; 7.继发性高血压患者。 

Exclusion criteria:

1. Significant arrhythmias, atrioventricular block, liver dysfunction, kidney dysfunction, pulmonary disease, endocrine disease, any other diseases or pathological conditions that can interfere with the experimental results; 2. Serious hearing, visual impairment or other conditions that hamper communication with the subjects; 3. Long-term administration of sedative(s), hypnotic(s), antidepressant(s); 4. A history of cerebral infarction, other central nervous system diseases, organic brain diseases or mental illness; 5. Alcohol or drug addiction; 6. Known allergy to study drugs; 7. Secondary hypertension. 

研究实施时间:

Study execute time:

From2016-09-05To 2018-03-30 

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

normal saline

Intervention code:

组别:

试验组

样本量:

50

Group:

dexmedetomidine group

Sample size:

干预措施:

dexmedetomidine

干预措施代码:

Intervention:

dexmedetomidine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

内蒙古自治区 

市(区县):

 

Country:

China 

Province:

Inner Mongolia Autonomous Region 

City:

 

单位(医院):

内蒙古医科大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Inner Mongolia medical university  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

MMSE

指标类型:

主要指标 

Outcome:

MMSE scores

Type:

Primary indicator 

测量时间点:

1 day before, 3days and 6 days after the operation

测量方法:

Measure time point of outcome:

1 day before, 3days and 6 days after the operation

Measure method:

指标中文名:

IL-6, TNF-α and CRP

指标类型:

主要指标 

Outcome:

The levels of IL-6, TNF-α and CRP

Type:

Primary indicator 

测量时间点:

before induction, 6h after the end of the operation and 24h after the end of the operation

测量方法:

Measure time point of outcome:

before induction, 6h after the end of the operation and 24h after the end of the operation

Measure method:

指标中文名:

NSE

指标类型:

主要指标 

Outcome:

The NSE levels

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HR, SBP, DBP, and ST segment changes in ECG

指标类型:

次要指标 

Outcome:

HR, SBP, DBP, and ST segment changes in ECG

Type:

Secondary 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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 60 years
最大 Max age 65 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):

随机数字化表

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

random number table

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

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):

临床试验公共管理平台http//www.dedresman.org/

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

临床试验公共管理平台http//www.dedresman.org/

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:

临床试验公共管理平台http//www.dedresman.org/

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

临床试验公共管理平台http//www.dedresman.org/

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-09-05
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