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围术期应用右美托咪定对血流动力学的影响
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注册号:

Registration number:

ChiCTR-IOR-17010423 

最近更新日期:

Date of Last Refreshed on:

2017-01-13 

注册时间:

Date of Registration:

2017-01-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

围术期应用右美托咪定对血流动力学的影响 

Public title:

Effects of dexmedetomidine on hemodynamics during perioperative period 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

围术期应用右美托咪定对血流动力学的影响 

Scientific title:

Effects of dexmedetomidine on hemodynamics during perioperative period 

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:

韩鏐 

研究负责人:

韩园 

Applicant:

Han Liu 

Study leader:

Han Yuan 

申请注册联系人电话:

Applicant telephone:

+86 15996960370 

研究负责人电话:

Study leader's telephone:

+86 13852470693 

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:

334903226@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

374198873@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:

中国江苏省徐州市泉山区淮海西路84号 

研究负责人通讯地址:

中国江苏省徐州市泉山区淮海西路99号 

Applicant address:

84 West Huaihai, Quanshan District, Xuzhou, Jiangsu, China 

Study leader's address:

99 West Huaihai, Quanshan District, Xuzhou, Jiangsu, 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:

 

申请人所在单位:

徐州医科大学 

Applicant's institution:

Xuzhou Medical Univetsity 

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:

xyfylw2014036 

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:

徐州医科大学附属医院伦理委员会 

Name of the ethic committee:

The Clinical Research Ethnics Committee of The Affiliated Hospital of Xuzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-11-04 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

徐州医科大学 

Primary sponsor:

Xuzhou Medical University 

研究实施负责(组长)单位地址:

中国江苏省徐州市泉山区淮海西路84号 

Primary sponsor's address:

84 West Huaihai, Quanshan District, Xuzhou, Jiangsu, 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):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

XuZhou

单位(医院):

徐州医科大学附属医院

具体地址:

中国江苏省徐州市泉山区淮海西路99号

Institution
hospital:

The Affiliated Hospital of Xuzhou Medical University

Address:

99 West Huaihai Road, Quanshan District, Xuzhou, Jiangsu

经费或物资来源:

徐州医科大学附属医院麻醉科 

Source(s) of funding:

Department of Anesthesiology,the Affiliated Hospital of Xuzhou Medical University 

研究疾病:

围术期血流动力学 

Target disease:

Perioperative hemodynamics 

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:

探讨右美托咪定在不同麻醉维持方式中对于血流动力学的影响。 

Objectives of Study:

To investigate the effects of dexmedetomidine on hemodynamics in different anesthesia maintenance methods. 

药物成份或治疗方案详述:

右美托咪定 

Description for medicine or protocol of treatment in detail:

Dexmedetomidine 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄在18岁至64岁之间,性别不限;(2)预计手术时间2h以上的患者;(3)ASA分级为I~II级;(4)肝、肾功能未见异常,无异常麻醉手术史;(5)患者基础收缩压小于160mmHg,舒张压小于90mmHg;(6)心率大于等于60次/分。 

Inclusion criteria

Between 18 and 65 years old; American Society of Anesthesiologists (ASA) grade I or II; operation time expected to more than 1h; baseline blood pressure lower than 160/90mmHg; heart rate greater than or equal to 60 bpm/ min; no liver and renal dysfunction and no abnormal anesthesia operation history.  

排除标准:

(1)心电图显示有窦性心动过缓、病窦综合征、房室传导阻滞者;(2)既往有高血压病3级以上者。(3)围术期应用血管抗高血压药物。 

Exclusion criteria:

ECG showed sinus tachycardia, sick sinus syndrome and atrioventricular block; use of cardioactive or antihypertensive medication in the preoperative period  

研究实施时间:

Study execute time:

From2014-07-01To 2016-03-31 

干预措施:

Interventions:

组别:

丙泊酚+右美组

样本量:

21

Group:

P+ DEX group

Sample size:

干预措施:

丙泊酚麻醉维持,负荷剂量右美

干预措施代码:

Intervention:

propofol for anesthesia maintenance, a loading dose of dexmedetomidine

Intervention code:

组别:

七氟烷+右美组

样本量:

21

Group:

S+ DEX group

Sample size:

干预措施:

七氟烷麻醉维持,负荷剂量右美

干预措施代码:

Intervention:

sevoflurane for anesthesia maintenance, a loading dose of dexmedetomidine

Intervention code:

组别:

丙泊酚+生理盐水组

样本量:

21

Group:

P+NS group

Sample size:

干预措施:

丙泊酚麻醉维持,等量生理盐水

干预措施代码:

Intervention:

propofol for anesthesia maintenance, volume-matched normal saline

Intervention code:

组别:

七氟烷+生理盐水组

样本量:

21

Group:

S+NS group

Sample size:

干预措施:

七氟烷麻醉维持,等量生理盐水

干预措施代码:

Intervention:

sevoflurane for anesthesia maintenance, volume-matched normal saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

徐州 

Country:

China 

Province:

Jiangsu 

City:

Xuzhou 

单位(医院):

徐州医科大学附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

主要指标 

Outcome:

heart rate

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 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):

我们邀请麻醉实施者(而非观察者)之一在试验之初使用SPSS编程进行完全随机设计分组

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

We invite one of the anesthesia implementers,but not observers, to use SPSS programming for our completely randomized design at the beginning of the trial.

盲法:

Blinding:

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):

2016年12月,通过ResMan查询

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

In Dec 2016,by ResMan

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:

包括每位患者术前、术中及术后数据的原始记录,整理过的表格,以及SPSS运行结果

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

Including the original pre-postoperative data of each patient,organized table,and the results run by SPSS.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-01-13
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