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依托咪酯和丙泊酚麻醉在冠心病人非心脏手术中的临床对照研究
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注册号:

Registration number:

ChiCTR1900025174 

最近更新日期:

Date of Last Refreshed on:

2019-08-15 

注册时间:

Date of Registration:

2019-08-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

依托咪酯和丙泊酚麻醉在冠心病人非心脏手术中的临床对照研究 

Public title:

Etomidate vs. propofol in patients with coronary disease undergoing Non-cardiac surgery: a randomised study. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

依托咪酯和丙泊酚麻醉在冠心病人非心脏手术中的临床对照研究 

Scientific title:

Etomidate vs. propofol in patients with coronary disease undergoing Non-cardiac surgery: a randomised study. 

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:

戴中亮 

研究负责人:

戴中亮 

Applicant:

Zhongliang Dai 

Study leader:

Zhongliang Dai 

申请注册联系人电话:

Applicant telephone:

+86 13530756996 

研究负责人电话:

Study leader's telephone:

+86 13530756996 

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:

daizhongliang@jnu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

daizhongliang@jnu.edu.cn 

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:

中国广东深圳市罗湖区东门北路1017号 

研究负责人通讯地址:

中国广东深圳市罗湖区东门北路1017号 

Applicant address:

1017 North Dongmen Road, Luohu District, Shenzhen, Guangdong, China 

Study leader's address:

1017 North Dongmen Road, Luohu District, Shenzhen, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

518020 

研究负责人邮政编码:

Study leader's postcode:

518020 

申请人所在单位:

深圳市人民医院 

Applicant's institution:

Shenzhen People's 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:

20140321 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

深圳市人民医院医学伦理委员会 

Name of the ethic committee:

Shenzhen People's Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

李亚丽 

Contact Name of the ethic committee:

Li Yali 

伦理委员会联系地址:

深圳市罗湖区东门北路1017号 

Contact Address of the ethic committee:

1017 North Dongmen Road, Luohu District, Shenzhen, Guangdong, 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:

深圳市人民医院 

Primary sponsor:

Shenzhen People's Hospital 

研究实施负责(组长)单位地址:

深圳市罗湖区东门北路1017号 

Primary sponsor's address:

1017 North Dongmen Road, Luohu District, Shenzhen, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

深圳市科技研发基金 

Source(s) of funding:

Shenzhen Science and Technology Research Fund 

研究疾病:

冠心病人 

Target disease:

coronary artery patients  

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:

本研究通过观察和比较依托咪酯脂肪乳和丙泊酚用于冠心病患者全麻期间的血流动力学变化,评价依托咪酯脂肪乳在冠心病患者非心脏手术中的应用价值。 

Objectives of Study:

By observing and comparing the effect on hemodynamic of propofol and etomidate emulsion that apply to patients with coronary heart disease during anesthesia, to evaluate the application value of etomidate in patients with coronary heart disease who need to receive non-cardiac surgery. 

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:

所选患者均明确既往冠心病病史,行普外科非心脏手术(包括甲状腺,肝胆,胃肠手术),美国麻醉医师协会(ASA)分级为Ⅱ~Ⅲ级,经由本院医学伦理委员会的批准并且同患者签订书面临床试验同意书。入选对象均提前告知试验流程并交代相关风险后签署知情同意书。 

Inclusion criteria

patients were selected for the history of previous coronary heart disease, general surgery non-cardiac surgery (including thyroid, hepatobiliary, gastrointestinal surgery), American Association of Anesthesiologists (ASA) graded II to III, approved by the Medical Ethics Committee of the hospital and Sign a written clinical trial consent form with the patient. The selected subjects were informed of the test procedure in advance and informed the relevant risks and signed the informed consent form. 

排除标准:

急诊手术或拟行心脏手术患者;合并有先天性心脏病,风湿性心脏病,心肌病、显著的左室肥大、过去3个月发生心梗、瓣膜病等严重心肺功能障碍,肝肾功能障碍,肾上腺皮质功能障碍,异常出血史,对丙泊酚或依托咪酯存在不良反应,安装起搏器,高血压3级及以上,低血压或休克,体重指数≥30 kg/m2,不同意签署知情同意书及不能完成试验流程的患者。 

Exclusion criteria:

Exclusion criteria were emergency surgery or patients undergoing cardiac surgery; combined with congenital heart disease, rheumatic heart disease, cardiomyopathy, significant left ventricular hypertrophy, severe myocardial infarction such as myocardial infarction and valvular disease in the past 3 months, liver Renal dysfunction, adrenal dysfunction, abnormal bleeding history, adverse reactions to propofol or etomidate, pacemaker, hypertension grade 3 and above, hypotension or shock, body mass index ≥ 30 kg/m2, Disagree with the signing of informed consent and patients who are unable to complete the testing process. 

研究实施时间:

Study execute time:

From2014-06-01To 2015-11-30 

征募观察对象时间:

Recruiting time:

From2014-06-01To 2015-12-31 

干预措施:

Interventions:

组别:

Group 2

样本量:

40

Group:

Group 2

Sample size:

干预措施:

丙泊酚麻醉

干预措施代码:

Intervention:

propofol

Intervention code:

组别:

Group 1

样本量:

40

Group:

Group 1

Sample size:

干预措施:

依托咪酯脂肪乳

干预措施代码:

Intervention:

etomidate emulsion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

血流动力学

指标类型:

主要指标 

Outcome:

Hemodynamics

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 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):

使用密封的信封进行随机化。 在手术当天,一名研究人员将一个信封随机带到手术室。 保持隐藏直到患者到达手术室,然后麻醉医生打开信封。 患者,数据收集者和数据分析员对所使用的麻醉类型不知情。

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

Randomization was performed using a sealed envelope. On the day of operation, an envelope was randomly taken to the operating room by one of the investigators. Concealment was maintained until the patient arrived in operating room, whereafter the consulting anaesthesiologist opened the envelope. Patients, data collecto

盲法:

未说明

Blinding:

Not stated

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

否No

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):

daizhongliang@jnu.edu.cn; ResMan

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

daizhongliang@jnu.edu.cn; 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:

CRF

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-15
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