经皮穴位电刺激条件下瑞芬太尼抑制老年患者拔除气管导管反应的半数有效浓度

注册号:

Registration number:

AMCTR-IOR-17000133 

注册号获得时间:

Date of releasing the registration number:

2018/3/14 15:58:29 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

经皮穴位电刺激条件下瑞芬太尼抑制老年患者拔除气管导管反应的半数有效浓度 

Public title:

The median effective concentration of remifentanil in the removal of tracheal tube response in elderly patients under percutaneous acupoint electrical stimulation 

研究课题的正式科学名称:

经皮穴位电刺激条件下瑞芬太尼抑制老年患者拔除气管导管反应的半数有效浓度 

Scientific title:

The median effective concentration of remifentanil in the removal of tracheal tube response in elderly patients under percutaneous acupoint electrical stimulation 

研究课题代号(代码):

Study subject ID:

河北省政府资助临床优秀人才培养和基础课题研究项目(361005) 

在其它机构的注册号:

Secondary ID:

ChiCTR-IOR-17013724 

申请注册联系人:

赵娟 

研究负责人:

王秋筠 

Applicant:

Juan Zhao 

Study leader:

Qiujun Wang 

申请注册联系人电话:

Applicant telephone:

+86 13386637139 

研究负责人电话:

Study leader's telephone:

+86 031 188602072 

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:

734460188@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

13933178001@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:

河北省石家庄市桥西区自强路139号 

研究负责人通讯地址:

河北省石家庄市桥西区自强路139号 

Applicant address:

139 Ziqiang Road, Shijiazhuang, Hebei, China 

Study leader's address:

139 Ziqiang 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:

河北医科大学第三医院 

Applicant's institution:

the Third 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:

2016-12-01 

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:

河北医科大学第三医院伦理委员会 

Name of the ethic committee:

Ethic Committee of the Third Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-01 

研究实施负责(组长)单位:

河北医科大学第三医院 

Primary sponsor:

the Third Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市桥西区自强路139号 

Primary sponsor's address:

139 Ziqiang 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

City:

Shijiazhuang

单位(医院):

河北医科大学第三医院

具体地址:

河北省石家庄市桥西区自强路139号

Institution
hospital:

the Third Hospital of Hebei Medical University

Address:

139 Ziqiang Road, Shijiazhuang, Hebei, China

经费或物资来源:

河北省政府资助临床优秀人才培养和基础课题研究项目(361005) 

Source(s) of funding:

Hebei Provincial Government Funded Clinical Talents Cultivation and Basic Research Projects (361005) 

研究疾病:

老龄患者 

Target disease:

Elderly patients 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

本研究拟探讨经皮穴位电刺激条件下瑞芬太尼抑制老年患者拔除气管导管反应的半数有效浓度。 

Objectives of Study:

The purpose of this study is to explore the half effective concentration of remifentanil in the removal of tracheal tube reaction in elderly patients under the condition of percutaneous acupoint electrical stimulation. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)全身麻醉下接受腰后路减压植骨融合内固定术的老年腰椎间盘突出症患者,ASA分级为I或II级,(2)无脑损伤,神经疾病及酗酒史,(3)术前无认知功能障碍,(4)无视觉和听力损伤,无明显的心肺肝肾功能异常 

Inclusion criteria

(1) Elderly patients with prolapse of lumbar intervertebral disc receiving Posterior lumbar decompression bone grafting and internal fixation under general anesthesia,American Society of Anesthesiologists' physical status classes I & II; (2) no history of traumatic brain injury, neurological diseases and alcohol abuse; (3) no cognitive dysfunction; (4) no severe vision or hearing impairment and no obvious abnormality of heart, lung, liver and kidney function. 

排除标准:

(1)手术时间超过3小时,(2)术中出血量超过800ml,(3)手术因各种原因被取消 

Exclusion criteria:

(1) Operation time is greater thsna3 hours; (2) The intraoperative blood loss is more than 800 ml; (3) The surgery was cancelled for various reasons. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

瑞芬太尼1组

样本量:

20

Group:

groups1 of remifentanil

Sample size:

干预措施:

经皮穴位电刺激

干预措施代码:

Intervention:

Electrical stimulation

Intervention code:

组别:

瑞芬太尼2组

样本量:

20

Group:

remifentanil anesthesia

Sample size:

干预措施:

经皮穴位电刺激

干预措施代码:

Intervention:

Electrical stimulation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

石家庄 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第三医院 

单位级别:

三甲医院 

Institution
hospital:

the Third 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 

指标中文名:

心率

指标类型:

主要指标 

Outcome:

heart rate

Type:

Primary indicator 

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

blood gluco

Type:

Primary indicator 

指标中文名:

动脉血二氧化碳分压

指标类型:

主要指标 

Outcome:

PaCO2

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 85 years

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

性别:

男女均可

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

The patients were grouped by a random number table by professional technicians

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

本课题组将于2021年6月使用ResMan 进行原始数据共享

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

Our group will use ResMan to share raw data in June 2021

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

实验数据使用ResMan 进行管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

The experimental data were managed using ResMan

创建人:

Creater Name:

 2017-12-08
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