腕踝针用于麻醉诱导期的研究

注册号:

Registration number:

AMCTR-IOR-19000286 

注册号获得时间:

Date of releasing the registration number:

2019/8/4 22:15:20 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

腕踝针用于麻醉诱导期的研究 

Public title:

A study for wrist and ankle acupuncture in induction period of anesthesia 

研究课题的正式科学名称:

腕踝针用于麻醉诱导期的研究 

Scientific title:

A study for wrist and ankle acupuncture in induction period of anesthesia 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900024773 

申请注册联系人:

徐哲 

研究负责人:

郝巍 

Applicant:

Zhe Xu 

Study leader:

Wei Hao 

申请注册联系人电话:

Applicant telephone:

+86 13933826335 

研究负责人电话:

Study leader's telephone:

+86 13832122359 

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:

xzhe1981@163.com 

研究负责人电子邮件:

Study leader's E-mail:

404613459@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 

Applicant's institution:

河北省中医院 

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:

2019-07-10 

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):

Hebei Hospital of Traditional Chinese Medicine

具体地址:

河北省石家庄市中山东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:

政府资助专科能力建设和专科带头人培养项目 

Source(s) of funding:

The government funds specialized capacity building and specialized leader training programs 

研究疾病:

围术期麻醉诱导 

Target disease:

Induction of perioperative anesthesia 

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:

对比常规诱导和应用腕踝针诱导后患者心血管波动发生率 

Objectives of Study:

The incidence of cardiovascular fluctuation was compared between routine induction and carpal and ankle needle induction 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 全麻气管插管患者 2. ASA I~Ⅱ级 3. Mallampati 分级为Ⅰ~Ⅲ级 4. 年龄>18岁,男女不限 5. 理解并签署知情同意书 

Inclusion criteria

1. Patients with general anesthesia tracheal intubation; 2. ASA I, II; 3. Mallampati I to III; 4. Aged > 18 years male or female; 5. Understand and sign the informed consent. 

排除标准:

1. 高血压术前未控制 2. 孕产妇 3. 语言沟通障碍 4. 合并病态肥胖、食管裂孔疝、胃食管反流病、胃排空延迟等疾病 5. 有阿片类药物过敏史 6. 术前应用潜在影响血压调节药物(利血平、降压0号等) 

Exclusion criteria:

1. Hypertension was not controlled before operation; 2. Pregnant and lying-in women; 3. Language communication barrier; 4. Combined with morbid obesity, hiatus hernia, gastroesophageal reflux disease, delayed gastric emptying and other diseases; 5. Have a history of opioid allergy; 6. Preoperative application of drugs potentially affecting blood pressure regulation (reserpine, no.0, etc.). 

研究实施时间:

Study execute time:

From2019-07-29To 2020-01-31 

干预措施:

Interventions:

组别:

实验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

腕踝针

干预措施代码:

Intervention:

wrist ankle acupuncture

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

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:

省级三甲医院 

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:

平均动脉压波动范围

指标类型:

主要指标 

Outcome:

Range of mean arterial pressure fluctuations

Type:

Primary indicator 

指标中文名:

心率波动范围

指标类型:

主要指标 

Outcome:

Range of heart rate fluctuations

Type:

Primary indicator 

指标中文名:

围术期恶心、呕吐发生率

指标类型:

次要指标 

Outcome:

Incidence of nausea and vomiting in perioperative period

Type:

Secondary indicator 

指标中文名:

围术期阿片类药物使用量

指标类型:

次要指标 

Outcome:

Perioperative opioid usage

Type:

Secondary indicator 

指标中文名:

血清炎性因子

指标类型:

主要指标 

Outcome:

Serum inflammatory factor

Type:

Primary indicator 

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

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):

随机数字表法

性别:

男女均可

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

random number table

Gender:

Both

盲法:

未说明

Blinding:

no state

试验完成后的统计结果:

点击下载

Calculated Results ater
the Study Completed:

download

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 published

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):

病例记录表

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

Case Record Form

创建人:

Creater Name:

 2019-08-04
返回列表