针刺内关穴对剖宫产术中卡前列素氨丁三醇不良反应的防治作用

注册号:

Registration number:

AMCTR-IOR-17000067 

注册号获得时间:

Date of releasing the registration number:

2018/3/15 21:32:56 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺内关穴对剖宫产术中卡前列素氨丁三醇不良反应的防治作用 

Public title:

The effectiveness of Nei-Guan Acupuncture in Preventing The adverses of Carboprost Tromethaminend during Caesarean Section 

研究课题的正式科学名称:

针刺内关穴对剖宫产术中卡前列素氨丁三醇不良反应的防治作用 

Scientific title:

The effectiveness of Nei-Guan Acupuncture in Preventing The adverses of Carboprost Tromethaminend during Caesarean Section 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR-IOR-17011631 

申请注册联系人:

缴宝杰 

研究负责人:

缴宝杰 

Applicant:

Jiao Baojie 

Study leader:

Jiao Baojie 

申请注册联系人电话:

Applicant telephone:

+86 15369844550 

研究负责人电话:

Study leader's telephone:

+86 15369844550 

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:

724187908@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

724187908@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:

河北省沧州市新华路16号 

研究负责人通讯地址:

河北省沧州市新华路16号 

Applicant address:

16 Xinhua Road, Cangzhou, Hebei, Chiina 

Study leader's address:

16 Xinhua Road, Cangzhou, Hebei, Chiina 

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:

沧州市中心医院 

Applicant's institution:

Cangzhou Central Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

沧州市中心医院 

Primary sponsor:

Cangzhou Central Hospital 

研究实施负责(组长)单位地址:

河北省沧州市新华路16号 

Primary sponsor's address:

16 Xinhua Road, Cangzhou, Hebei, Chiina 

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):

沧州市

Country:

China

Province:

Hebei

City:

Cangzhou

单位(医院):

沧州市中心医院

具体地址:

河北省沧州市新华路16号

Institution
hospital:

Cangzhou Central Hospital

Address:

16 Xinhua Road, Cangzhou, Hebei, Chiina

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

恶心呕吐 

Target disease:

PONV 

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:

探讨针刺内关穴对剖宫产术中卡前列素氨丁三醇不良反应的影响 

Objectives of Study:

To evaluate the efficacy of acupuncture acupuncture Neiguan point for prevention of the adverse 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

椎管内麻醉下行择期剖宫产的产妇,ASAI~II级,年龄25~40岁,体重55~80kg,术中因宫缩乏力而使用卡前列素氨丁三醇宫体注射治疗的患者 

Inclusion criteria

parturients of ASA physical status I or II, aged 25-40 years, weighing 55-80 kg,with factors for uterine atony undergoing elective cesarean section under epidural anesthesia 

排除标准:

产科合并症,如高血压、心脏病、糖尿病、哮喘等,术前有恶心、呕吐、胸闷等不良反应 

Exclusion criteria:

Obstetric complications, such as high blood pressure, heart disease, diabetes, asthma, etc., preoperative has the adverse reactions such as nausea, vomiting, chest tightness 

研究实施时间:

Study execute time:

From2017-05-01To 2017-09-01 

干预措施:

Interventions:

组别:

生理盐水组

样本量:

30

Group:

saline group

Sample size:

干预措施:

静主生理盐水10ml

干预措施代码:

Intervention:

normal saline10ml iv

Intervention code:

组别:

昂丹司琼组

样本量:

30

Group:

ondansetron group

Sample size:

干预措施:

静注昂丹司琼4mg

干预措施代码:

Intervention:

ondansetron 4mg iv

Intervention code:

组别:

针组

样本量:

30

Group:

acupuncture group

Sample size:

干预措施:

针刺内关穴组

干预措施代码:

Intervention:

acupuncture Neiguan point

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):

沧州市 

Country:

China 

Province:

Hebei 

City:

Cangzhou 

单位(医院):

沧州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Cangzhou central hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

恶心呕吐

指标类型:

主要指标 

Outcome:

PONV

Type:

Primary indicator 

指标中文名:

血流动力学指标

指标类型:

次要指标 

Outcome:

hemodynamics

Type:

Secondary indicator 

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 25 years
最大 Max age 40 years

随机方法(请说明由何人用什么方法产生随机序列):

专人采用随机数字表进行分组

性别:

女性

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

The specialist according to a random digital table for grouping

Gender:

Female

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:

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):

N/A

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

N/A

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):

N/A

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

N/A

创建人:

Creater Name:

 2017-06-12
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