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丙泊酚复合纳布啡用于ERCP的麻醉效果观察
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注册号:

Registration number:

ChiCTR1800016018 

最近更新日期:

Date of Last Refreshed on:

2018-05-07 

注册时间:

Date of Registration:

2018-05-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

丙泊酚复合纳布啡用于ERCP的麻醉效果观察 

Public title:

Efficacy of nalbuphine combined with propofol anesthesia in patients undergoing endoscopic retrograde cholangiopancreatography 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

丙泊酚复合纳布啡用于内镜微创治疗的麻醉效果观察 

Scientific title:

Anesthetic effects of nalbuphine combined with propofol on patients receiving endoscopic mini-invasive therapy 

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:

陈燕 

研究负责人:

米卫东 

Applicant:

Chen Yan 

Study leader:

Mi Wei-dong 

申请注册联系人电话:

Applicant telephone:

+86 13611396706 

研究负责人电话:

Study leader's telephone:

+86 13381082966 

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:

yanzicw@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wwdd1962@aliyun.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:

北京市海淀区复兴路28号解放军总医院麻醉手术中心 

研究负责人通讯地址:

北京市海淀区复兴路28号解放军总医院麻醉手术中心 

Applicant address:

28 Fuxing Road, Haidian, Beijing, China 

Study leader's address:

28 Fuxing Road, Hai Dian, Beijing, 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:

中国人民解放军总医院麻醉手术中心 

Applicant's institution:

Anesthesia and Operation Center, Chinese PLA General 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:

S2017-075-02 

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:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

Institutional Review Board of Chinese PLA General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-27 

伦理委员会联系人:

曹江 

Contact Name of the ethic committee:

Cao Jiang 

伦理委员会联系地址:

北京市海淀区复兴路28号 

Contact Address of the ethic committee:

28 Fuxing Road, Haidian, Beijing, 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:

中国人民解放军总医院 

Primary sponsor:

Chinese PLA General Hospital 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Haidian, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Chinese PLA General Hospital

Address:

28 Fuxing Road, Haidian, Beijing, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

ERCP的麻醉管理 

Target disease:

Anesthetic management of ERCP procedure 

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:

探讨丙泊酚复合纳布啡用于ERCP术的有效性和安全性。 

Objectives of Study:

To explore the efficacy and safety of nalbuphine combined with propofol anesthesia in patients undergoing endoscopic retrograde cholangiopancreatography. 

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、拟行ERCP术的患者 2、年龄18-80岁 3、体重指数(BMI)18.5-30 kg/m2 4、美国麻醉医师协会(ASA)分级为Ⅰ-Ⅲ级 

Inclusion criteria

1. Patients receiving ERCP procedure; 2. Aged from 18 to 80 years old; 3. Body mass index ranged from 18.5 to 30 kg/m2; 4. ASA graded I-III. 

排除标准:

1、有严重心血管疾病、肝肾功能障碍者 2、消化道梗阻或反流误吸风险大的患者 3、有抗胆碱能药物使用禁忌症,如青光眼、幽门梗阻、反流性食管炎等 4、安置心脏起搏器者 5、既往有异常麻醉恢复史者 6、血红蛋白低于80g/L者 7、有滥用麻醉性镇痛药或镇静药者 8、已知对乳剂、阿片类药物过敏者 9、有精神疾病及不配合无法沟通者  

Exclusion criteria:

1. Patients with severe cardiovascular diseases, hepatic or renal insufficiency; 2. patients who have increased risk of alimentary tract obstruction, regurgitation and aspiration; 3. Patients who have contraindication of anticholinergic agents, such as glaucoma,pyloric obstruction and reflux esophagitis; 4. Patients fitted with a pacemaker; 5. A history of abnormal anesthesia recovery; 6. Hemoglobin less than 80g/L; 7. Abuse of opioids or sedative drugs; 8. Allergy to emulsion or opioids; 9. Patients who have mental disorders or are unable to communicate properly. 

研究实施时间:

Study execute time:

From2018-05-01To 2019-04-30 

征募观察对象时间:

Recruiting time:

From2018-05-01To 2019-04-30 

干预措施:

Interventions:

组别:

2

样本量:

200

Group:

2

Sample size:

干预措施:

静脉推注咪达唑仑1mg后,先静脉滴注纳布啡5mg,再静脉推注丙泊酚1-2mg/kg,待患者睫毛反射消失后开始进镜

干预措施代码:

Intervention:

After intravenous injection of midazolam 1mg, intravenous nalbuterine 5mg will be injected intravenously and propofol 1-2mg/kg will be injected intravenously.

Intervention code:

组别:

1

样本量:

200

Group:

1

Sample size:

干预措施:

静脉推注咪达唑仑1mg后,先静脉注射芬太尼50ug,再静脉推注丙泊酚1-2mg/kg,待患者睫毛反射消失后开始进镜

干预措施代码:

Intervention:

After intravenous injection of midazolam 1mg, fentanyl 50ug will be injected intravenously and propofol 1-2mg/kg will be injected intravenously.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲医院 

Institution
hospital:

Chinese PLA general hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

低氧血症

指标类型:

主要指标 

Outcome:

Hypoxemia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

上呼吸道梗阻

指标类型:

主要指标 

Outcome:

Upper airway obstruction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸暂停

指标类型:

主要指标 

Outcome:

Apnea

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体动评分

指标类型:

主要指标 

Outcome:

Score of somatic movement

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

一名不参与试验实施和观察全过程的人员采用R3.1.1的blockrand程序包进行随机区段分组,样本量为400,组数设为2(A和B组),区段大小为4,随机数种子为1000,从而得到每个编号(1到400)对应的组别(A或B组)。

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

A researcher who does not participate in the process of the trial performs the randomization procedure. The random number sequence was generated by block randomization using blockrand program package R3.1.1. The sample size was 400, grouping number was two,block length was four, and random seed was 1000.

盲法:

Blinding:

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):

原始数据将于2019年5月1日至10月31日期间在院内网公开。

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

The original data will be available online in our hospital from May 1 to October 31, 2019

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:

病例记录表(CRF)由一名麻醉医生记录,患者生命体征监测由电子病例信息系统自动采集。

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

The Case Record Form (CRF) was recorded by a anesthetist and the vital signs of a patient were collected by an electronic data capture.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-05-07
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