揿针耳穴在全麻插管中对自主神经及血流动力学的影响

注册号:

Registration number:

AMCTR-IPR-19000287 

注册号获得时间:

Date of releasing the registration number:

2019/8/4 22:19:20 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

揿针耳穴在全麻插管中对自主神经及血流动力学的影响 

Public title:

Effect of press needle on autonomic nerve and hemodynamics in general anesthesia intubation 

研究课题的正式科学名称:

揿针耳穴在全麻插管中对自主神经及血流动力学的影响 

Scientific title:

Effect of press needle on autonomic nerve and hemodynamics in general anesthesia intubation 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

何涛 

研究负责人:

何涛 

Applicant:

He Tao 

Study leader:

He Tao 

申请注册联系人电话:

Applicant telephone:

+86 15833213380 

研究负责人电话:

Study leader's telephone:

+86 15833213380 

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:

zest2030@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zest2030@sina.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:

河北省石家庄市中山东路389号 

研究负责人通讯地址:

河北省石家庄市中山东路389号 

Applicant address:

389 Zhongshan Road East, Shijiazhuang, Hebei, China 

Study leader's address:

389 Zhongshan Road East, 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:

河北省中医院麻醉科 

Applicant's institution:

Department of anesthesiology, Hebei Hospital of Traditional Chinese Medicine 

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:

2019-KY-012-01 

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:

河北省中医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Hebei Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-16 

研究实施负责(组长)单位:

河北省中医院 

Primary sponsor:

Hebei Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

河北省石家庄市中山东路389号 

Primary sponsor's address:

389 Zhongshan Road East, 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):

Country:

China

Province:

Hebei

City:

单位(医院):

河北省中医院

具体地址:

河北省石家庄市中山东路389号

Institution
hospital:

Hebei Hospital of Traditional Chinese Medicine

Address:

389 Zhongshan Road East, Shijiazhuang, Hebei, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

围术期外科手术病人 

Target disease:

Perioperative surgical patien 

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:

预实验 

Study phase:

Polit 

研究目的:

评估揿针干预全麻插管病人围手术期血流动力学及自主神经功能的影响 

Objectives of Study:

To evaluate the effect of acupuncture on perioperative hemodynamics and autonomic nerve function in patients with general anesthesia 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

纳入标准 1.年龄≥18 岁,<80岁 2.ASA I~Ⅱ 3.拟行择期全麻插管手术患者 受试者签署知情同意书 

Inclusion criteria

1. Aged 18 to 80 years old; 2. ASA I ~ II; 3. Patients planning to undergo elective general anesthesia intubation; 4. Subjects sign informed consent form. 

排除标准:

1.脑血管疾病患者 2.中枢神经系统疾病患者 3.正在使用精神类药品治疗 4.酒精或阿片类药物滥用史 5.入选研究前 3 月服用了其他试验药或者是参与了其他临床试验 6.皮肤破损不能行针灸者 任何原因不能配合研究或研究者认为不宜纳入本试验 

Exclusion criteria:

1. Cerebrovascular disease patients; 2. Patients with central nervous system diseases; 3. She is being treated with psychotropic drugs; 4. History of alcohol or opioid abuse; 5. Taking other drugs or participating in other clinical trials 3 months prior to study inclusion; 6. The skin is damaged and cannot be used for acupuncture; 7. Any reason is not compatible with the study or the researcher considers it unsuitable to be included in this study. 

研究实施时间:

Study execute time:

From2019-07-17To 2020-07-16 

干预措施:

Interventions:

组别:

Group 1

样本量:

50

Group:

Group 1

Sample size:

干预措施:

耳针

干预措施代码:

Intervention:

earpins

Intervention code:

组别:

对照组

样本量:

50

Group:

Group 2

Sample size:

干预措施:

干预措施代码:

Intervention:

No

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):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北省中医院 

单位级别:

三级甲等 

Institution
hospital:

Hebei Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

动脉血压

指标类型:

主要指标 

Outcome:

Arterial blood pressure

Type:

Primary indicator 

指标中文名:

去甲肾上腺素

指标类型:

次要指标 

Outcome:

noradrenaline

Type:

Secondary 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 18 years
最大 Max age 80 years

随机方法(请说明由何人用什么方法产生随机序列):

数字随机表

性别:

男女均可

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

Numerical random table

Gender:

Both

盲法:

未说明

Blinding:

Not stated

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

不公开

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

not to public

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):

病历记录表

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

Medical record

创建人:

Creater Name:

 2019-08-04
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