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盐酸右美托咪啶改善焦虑程度降低冠状动脉旁路移植术后患者新发心房纤颤的研究
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注册号:

Registration number:

ChiCTR1800014314 

最近更新日期:

Date of Last Refreshed on:

2018-01-05 

注册时间:

Date of Registration:

2018-01-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

盐酸右美托咪啶改善焦虑程度降低冠状动脉旁路移植术后患者新发心房纤颤的研究 

Public title:

Efficiency of Dexmedetomidine administration for relieving anxiety to prevent new-onset postoperative atrial fibrillation in patients undergoing off-pump coronary artery bypass graft 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

盐酸右美托咪啶改善焦虑程度降低冠状动脉旁路移植术后患者新发心房纤颤的研究 

Scientific title:

Efficiency of Dexmedetomidine administration for relieving anxiety to prevent new-onset postoperative atrial fibrillation in patients undergoing off-pump coronary artery bypass graft 

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:

谭琦 

研究负责人:

谭琦 

Applicant:

Tan Qi 

Study leader:

Tan Qi 

申请注册联系人电话:

Applicant telephone:

+86 18753157303 

研究负责人电话:

Study leader's telephone:

+86 18753157303 

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:

81453381@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

81453381@qq.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:

山东省济南市经十路9677号 

研究负责人通讯地址:

山东省济南市经十路9677号 

Applicant address:

9677 Jingshi Road, Ji'nan, China. 

Study leader's address:

9677 Jingshi Road, Ji'nan , China. 

申请注册联系人邮政编码:

Applicant postcode:

250014 

研究负责人邮政编码:

Study leader's postcode:

250014 

申请人所在单位:

山东省立医院 

Applicant's institution:

Shandong Provincial Hospital 

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:

2018-201 

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:

山东大学附属省立医院医学伦理委员会 

Name of the ethic committee:

Shandong Provincial Hospital Affillated to Shandong University Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-02 

伦理委员会联系人:

周小明 

Contact Name of the ethic committee:

Zhou Xiaoming 

伦理委员会联系地址:

山东省济南市经十路9677号 

Contact Address of the ethic committee:

9677 Jingshi Road, Ji'nan, China. 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

山东省立医院 

Primary sponsor:

Shandong Provincial Hospital 

研究实施负责(组长)单位地址:

山东省济南市经十路9677号 

Primary sponsor's address:

9677 Jingshi Road, Ji'nan, 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):

山东省

市(区县):

济南市

Country:

Chian

Province:

Shandong

City:

Jinan

单位(医院):

山东省立医院

具体地址:

山东省济南市经十路9677号

Institution
hospital:

Shandong Provincial Hospital

Address:

9677 Jingshi Road, Ji'nan 250014, China.

经费或物资来源:

经费自筹 

Source(s) of funding:

Self-funding 

研究疾病:

术后新发房颤 

Target disease:

new-onset of postoperative atrial fibrillation 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

(1)评估不停跳冠脉旁路移植术围手术期患者焦虑程度变化,血液中儿茶酚胺水平变化; (2)评估术后应用盐酸右美托咪啶能够改善患者焦虑程度,并降低新发房颤的发生率。 

Objectives of Study:

(1) To evaluate the status of anxiety in patients before and after off-pump coronary artery bypass graft, and the changes of catecholamine level in blood; (2) To evaluate the application of dexmetomidine after operation improving anxiety state and decreasing the incidence ofnew-onset of postoperative atrial fibrillation. 

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:

纳入标准:1.年龄大于等于18岁;2.择期行不停跳冠状动脉旁路移植术患者;3. 签署知情同意书。  

Inclusion criteria

1. aged>18 years; 2. undergoing elective OPCABG; 3. willingness to provide informed consent.  

排除标准:

排除标准:1.急性心肌梗死;2.合并瓣膜疾病;3.心律失常;4.既往精神疾病病史5.对右美托咪定或丙泊酚过敏或其它有使用禁忌症。 

Exclusion criteria:

1. active myocardial ischemia; 2. cardiac valvular dysfunction; 3. arrhythmias (permanent or paroxysmal AF, supraventricular tachycardia, ventricular arrhythmia, second- or third-degree heart block, permanent pacemaker, and/or defibrillator); 4. history of psychiatric disorders (schizophrenia, mania, psychosis); 5. allergic to DEX or PROP (Propofol). 

研究实施时间:

Study execute time:

From2017-01-01To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2017-01-01To 2018-06-30 

干预措施:

Interventions:

组别:

盐酸右美托咪定组

样本量:

52

Group:

dexmedetomidine group

Sample size:

干预措施:

0.2-1.0ug/kg/h泵入

干预措施代码:

Intervention:

infusion at a rate of 0.2-1.0ug/kg/h

Intervention code:

组别:

丙泊酚

样本量:

50

Group:

propofol group

Sample size:

干预措施:

0.1-3.0mg/kg/h泵入

干预措施代码:

Intervention:

infusion at a rate of 0.1-3.0mg/kg/h

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

济南市 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东省立医院 

单位级别:

三级甲等 

Institution
hospital:

Shandong Provincial Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

焦虑评分

指标类型:

主要指标 

Outcome:

anxiety scale

Type:

Primary indicator 

测量时间点:

术前和术后

测量方法:

Zung焦虑自评量表

Measure time point of outcome:

preoperative or postoperative

Measure method:

Zung’s Self-Rating Anxiety Scale

指标中文名:

术后新发心房纤颤

指标类型:

主要指标 

Outcome:

new-onset of postoperative atrial fibrillation

Type:

Primary indicator 

测量时间点:

术后

测量方法:

心电图

Measure time point of outcome:

postoperative

Measure method:

electrocardiograph

指标中文名:

儿茶酚胺水平

指标类型:

次要指标 

Outcome:

new-onset of postoperative atrial fibrillation

Type:

Secondary indicator 

测量时间点:

术前和术后

测量方法:

试剂盒

Measure time point of outcome:

preoperative and postoperative

Measure method:

ELISA

指标中文名:

心脏彩超指标

指标类型:

次要指标 

Outcome:

cardiac color ultrasound

Type:

Secondary indicator 

测量时间点:

术前和术后

测量方法:

心脏彩超

Measure time point of outcome:

preoperative and postoperative

Measure method:

color Doppler echocardiography

指标中文名:

术后多脏器功能

指标类型:

次要指标 

Outcome:

multi-organ complication

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 18 years
最大 Max age 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):

计算机软件excel生成随机区组数字

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

randomization was created by software Excel

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

是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):

研究原始数据预计将于2018年10月在临床试验公共管理平台ResMan发布

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

The study results will be published in Clinical Trial Management Public Platform in October 2018.

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:

研究数据直接记录于实验记录本,并转换成电子数据保存于计算机中,通过统计学软件绘制统计图表。

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

The study date will be recorded in our lab notebook and transformed into electric date in computers. we will draw charts from statistics results by statistical software.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-05
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