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右美托咪定与丙泊酚镇静在心脏术后患者中的比较研究
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注册号:

Registration number:

ChiCTR-IPR-16008231 

最近更新日期:

Date of Last Refreshed on:

2016-04-06 

注册时间:

Date of Registration:

2016-04-06 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

右美托咪定与丙泊酚镇静在心脏术后患者中的比较研究 

Public title:

Comparison of Dexmedetomidine versus Propofol for Sedation in patients after cardiac surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

右美托咪定与丙泊酚镇静对心脏术后患者房颤等并发症及预后的影响 

Scientific title:

Effects of Dexmedetomidine and Propofol Sedation on the incidence of postoperative atrial fibrillation and outcomes in patients after cardiac surgery 

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:

刘旭 

研究负责人:

方向明 

Applicant:

Liu Xu 

Study leader:

Xiangming Fang 

申请注册联系人电话:

Applicant telephone:

+86 15902501507 

研究负责人电话:

Study leader's telephone:

+86 13857161019 

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:

262347762@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xiangming_fang@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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学附属第一医院 

Applicant's institution:

the First Affiliated Hospital of Zhejiang 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:

2016-228 

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:

浙江大学医学院附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital,College of Medicine,Zhejiang University  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-03-25 

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:

浙江大学附属第一医院 

Primary sponsor:

the First Affiliated Hospital of Zhejiang University  

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-funded 

研究疾病:

心脏外科术后镇静 

Target disease:

sedation after cardiac surgery  

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:

比较右美托咪定与丙泊酚术后镇静对心脏手术患者术后并发症(如房颤)及预后等的影响,为优化心脏术后患者镇静治疗进一步提供依据。 

Objectives of Study:

The objective of this study is to investigate and compare the effects of the first-line sedatives propofol and dexmedetomidine on outcomes especially the incidence of postoperative atrial fibrillation in patients after cardiac surgery. This proposal is a clinical trial designed to reduce atrial fibrillation in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, antinociceptive and antiarrhythmic properties. Postoperative complications, motality and resource utilization analysis will be performed to determine cost effectiveness of the dexmedetomidine sedation modality. 

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.年龄大于等于18岁;2.择期心脏外科术后;3.术后即入住重症监护病房(ICU)并需行机械通气。 

Inclusion criteria

1. aged 18 years or older; 2. selective cardiac surgery; 3. Admitted to intensive care unit and received invasive mechanical ventilation. 

排除标准:

1.急性神经功能障碍;2.平均动脉压小于55mmHg(即使有合适的液体复苏和血管活性药物使用);3.心率小于50次/min;4.Ⅱ度或Ⅲ度房室传导阻滞(除外装有起搏器患者);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. acute severe neurological disorder; 2. mean arterial pressure less than 55mmHg despite appropr-iate intravenous volume replacement and vasopressors; 3. heart rate less than 50/min; 4. atrioventricular-conduction grade II or III (unless pacemaker installed); 5. of dexmedetomidine or propofol allergy or other contradications. 

研究实施时间:

Study execute time:

From2015-01-01To 2017-06-30 

征募观察对象时间:

Recruiting time:

From2015-01-01To 2016-06-30 

干预措施:

Interventions:

组别:

丙泊酚组

样本量:

90

Group:

Propofol group

Sample size:

干预措施:

丙泊酚

干预措施代码:

Intervention:

propofol

Intervention code:

组别:

右美托咪定组

样本量:

90

Group:

Dexmedetomidine Group

Sample size:

干预措施:

右美托咪定

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):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

the First Affiliated Hospital of Zhejiang University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

the First Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后房颤

指标类型:

主要指标 

Outcome:

Postoperative atrial fibrillation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性肾损伤

指标类型:

主要指标 

Outcome:

Acute kidney injury

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谵妄

指标类型:

次要指标 

Outcome:

Delirium

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感染

指标类型:

次要指标 

Outcome:

Infection

Type:

Secondary 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:

次要指标 

Outcome:

Length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院时间

指标类型:

主要指标 

Outcome:

Postoperative length of hospital stay

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ICU时间

指标类型:

主要指标 

Outcome:

Length of ICU stay

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

主要指标 

Outcome:

Hospital fees

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气时间

指标类型:

次要指标 

Outcome:

Mechanical ventilation time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低血压

指标类型:

副作用指标 

Outcome:

Hypotension

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心动过缓

指标类型:

副作用指标 

Outcome:

Bradycardia

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶心呕吐

指标类型:

副作用指标 

Outcome:

nausea and vomiting

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1年病死率

指标类型:

次要指标 

Outcome:

one year mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

舌下微循环

指标类型:

附加指标 

Outcome:

Sublingual microcirculation

Type:

Additional 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:

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):

将患者分层后,由主要研究者用随机数字表法分组

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

lead researcher use random number table to divide the patients into two groups after the patients stratified by preoperative atrial fibrillation and cardiopulmonary bypass

盲法:

Blinding:

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:

即时公开/Real time access

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):

在整体试验结束后在ResMan共享原始数据

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

after the whole study was completed the IPD will be accessable at the public clinical trial management database 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:

Excel表格,网络数据库

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

Excel forms, network database

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-04-06
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