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右美托咪定复合瑞芬太尼用于结肠镜检查的效果
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注册号:

Registration number:

ChiCTR2000029105 

最近更新日期:

Date of Last Refreshed on:

2020-01-13 

注册时间:

Date of Registration:

2020-01-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

右美托咪定复合瑞芬太尼用于结肠镜检查的效果 

Public title:

Effect of Dexmedetomidine Combined with Remifentanil for Patients with Colonoscopy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

右美托咪定复合瑞芬太尼用于结肠镜检查的效果 

Scientific title:

Effect of Dexmedetomidine Combined with Remifentanil for Patients with Colonoscopy 

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:

张静 

研究负责人:

贾丽 

Applicant:

Zhang Jing 

Study leader:

Jia Li 

申请注册联系人电话:

Applicant telephone:

+86 15031179825 

研究负责人电话:

Study leader's telephone:

+86 13933089766 

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:

2399606575@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

281575038@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:

河北省石家庄市健康路12号 

研究负责人通讯地址:

河北省石家庄市健康路12号 

Applicant address:

12 Jiankang Road, Shijiazhuang, Hebei, China 

Study leader's address:

12 Jiankang Road, Shijiazhuang, Hebei, 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:

河北医科大学第四医院 

Applicant's institution:

the Fourth Hospital of Hebei 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:

2017MEC113 

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:

河北医科大学第四医院药物临床试验伦理委员会 

Name of the ethic committee:

Ethics Committee for Drug Clinical Trial of the Fourth Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

张俊敏 

Contact Name of the ethic committee:

Zhang Jun-min 

伦理委员会联系地址:

河北省石家庄市健康路12号 

Contact Address of the ethic committee:

12, Jiankang Road, Shijiazhuang, Hebei, 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:

河北医科大学第四医院 

Primary sponsor:

the Fourth Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市健康路12号 

Primary sponsor's address:

12 Jiankang Road, Shijiazhuang, Hebei, 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):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei Province

City:

Shijiazhuang City

单位(医院):

河北医科大学第四医院

具体地址:

河北省石家庄市健康路12号

Institution
hospital:

the Fourth Hospital of Hebei Medical University

Address:

12 Jiankang Road

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

无痛结肠镜 

Target disease:

Painless Colonoscopy 

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:

本研究拟评价不同剂量的右美托咪定复合瑞芬太尼用于结肠镜检查和治疗的效果,为临床提供最佳方案。 

Objectives of Study:

The purpose of this study is to evaluate the effect of different dosage of demedetomidine(DEX) combined with remifentanil for patients with painless colonoscopy. 

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:

①ASA分级I~II级;②年龄45~64岁,性别不限。 

Inclusion criteria

1. ASA grade I-II; 2. aged 45-64 years. 

排除标准:

①合并窦性心动过缓; ②合并房室传导阻滞; ③患者拒绝。 

Exclusion criteria:

1. with sinus bradycardia; 2. with atrioventricular block; 3. patient refusal. 

研究实施时间:

Study execute time:

From2018-02-01To 2018-10-31 

征募观察对象时间:

Recruiting time:

From2017-12-01To 2018-02-01 

干预措施:

Interventions:

组别:

I组

样本量:

50

Group:

Group I

Sample size:

干预措施:

右美托咪定0.2μg·kg-1

干预措施代码:

Intervention:

DEX 0.2ug/kg

Intervention code:

组别:

II组

样本量:

50

Group:

Group II

Sample size:

干预措施:

右美托咪定0.3μg·kg-1

干预措施代码:

Intervention:

DEX 0.3ug/kg

Intervention code:

组别:

III组

样本量:

50

Group:

Group III

Sample size:

干预措施:

右美托咪定0.4μg·kg-1

干预措施代码:

Intervention:

DEX 0.4ug/kg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄市 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第四医院 

单位级别:

三甲医院 

Institution
hospital:

the Fourth Hospital of Hebei 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:

指标中文名:

血氧饱和度

指标类型:

主要指标 

Outcome:

SpO2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸频率

指标类型:

主要指标 

Outcome:

Respiratory Rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑电双频谱指数

指标类型:

主要指标 

Outcome:

BIS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度

指标类型:

主要指标 

Outcome:

Satisfaction Degree

Type:

Primary indicator 

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:

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:

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:

手术时间

指标类型:

次要指标 

Outcome:

Operation Time

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:

组织:

Sample Name:

none

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 64 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):

由专业技术人员采用随机数字表法对纳入患者进行分组。

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

The patients were divided into groups by using the random number table method.

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

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):

试验完成后6个月内使用ResMan进行原始数据共享, http://www.medresman.org.cn.

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

ResMan will be used for raw data sharing within 6 months after the end of the experiment, http://www.medresman.org.cn.

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:

试验完成后6个月内使用ResMan进行原始数据管理

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

ResMan was used to manage the original data within 6 months after the end of the experiment

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-13
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