Today is 2020-07-05

Effect of low dose dexmedetomidine nasal drops aid epidural labor analgesia in parturient women: a randomized controlled trial.
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注册号:

Registration number:

ChiCTR2000033356 

最近更新日期:

Date of Last Refreshed on:

2020-05-29 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

小剂量右美托咪定滴鼻辅助硬膜外分娩镇痛的临床效果观察 

Public title:

Effect of low dose dexmedetomidine nasal drops aid epidural labor analgesia in parturient women: a randomized controlled trial. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

小剂量右美托咪啶滴鼻辅助硬膜外分娩镇痛的临床效果观察 

Scientific title:

Effect of low dose dexmedetomidine nasal drops aid epidural labor analgesia in parturient women 

研究课题代号(代码):

Study subject ID:

合卫科教〔2019〕160号 

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:

朱海娟 

研究负责人:

张野 

Applicant:

Haijuan Zhu 

Study leader:

Ye Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13966778885 

研究负责人电话:

Study leader's telephone:

+86 13966768081 

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:

35880762@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangye_hassan@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:

合肥市益民街15号 

研究负责人通讯地址:

合肥市经开区芙蓉路678号 

Applicant address:

15 Yimin Road, Hefei, Anhui, China  

Study leader's address:

678 Furong Road, Economic Development Zone, Hefei, Anhui, 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:

安徽省合肥市妇幼保健院 

Applicant's institution:

Hefei Maternal and Child Heath 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:

2017审(10)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

合肥市妇幼保健院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Hefei Maternal and Child Health Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-05-18 

伦理委员会联系人:

张彬 

Contact Name of the ethic committee:

Bin Zhang 

伦理委员会联系地址:

安徽省合肥市益民路15号合肥市妇幼保健院科教部  

Contact Address of the ethic committee:

Department of Science and Education of Hefei Maternal and Child Health Hospital, 15 Yimin Road, Hefei, Anhui, 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:

安徽医科大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Anhui Medical University 

研究实施负责(组长)单位地址:

合肥市经开区芙蓉路678号 

Primary sponsor's address:

678 Furong Road, Economic Development Zone, Hefei, Anhui, 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):

安徽

市(区县):

合肥

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

安徽省合肥市妇幼保健院

具体地址:

安徽省合肥市益民路15号

Institution
hospital:

Hefei Maternal and Child Heath Hospital

Address:

15 Yimin Road, Hefei, Anhui, China

经费或物资来源:

合肥市第六周期重点培育专科项目(合卫科教〔2019〕160号);合肥市卫生计生委2017年应用医学研究项目(hwk2017zd003) 

Source(s) of funding:

Hefei the sixth cycle key cultivation specialist project (hewei science and education [2019] no. 160); Hefei health and family planning medical research project in 2017 (hwk2017zd003). 

研究疾病:

孕足月阴道分娩 

Target disease:

Vaginal delivery with full term 

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:

探索性研究/预试验 

Study phase:

研究目的:

拟在硬膜外穿此前15分钟给予小剂量右美托咪定滴鼻,拟达到缓解产妇紧张情绪、增加硬膜外穿刺操作时的配合度以及加快药物起效的目的。 

Objectives of Study:

A low-dose of dexmedetomidine is administered 15 minutes before epidural puncture to relieve maternal stress, increase coordination during epidural puncture, and accelerate drug efficacy. 

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:

ASAⅠ或Ⅱ级的孕足月初产单胎妊娠;年龄20~35 岁。 

Inclusion criteria

1. The first trimester of ASA I or II is a single pregnancy; 2. Subjects aged 20-35 years. 

排除标准:

1. 心率<50次/min; 2. 体重指数>35 kg/m2; 3. 有严重心肺疾患、精神疾患及椎管内穿刺禁忌症者; 4. 严重妊娠期合并症者; 5. 孕周不足36周者。 

Exclusion criteria:

1. Subjects with heart rate < 50 times / min; 2. Subjects with body mass index > 35 kg / m2; 3. Patients with severe cardiopulmonary disease, mental disease and contraindications of intraspinal puncture; 4. Patients with serious pregnancy complications; 5. Subjects with gestational age less than 36 weeks. 

研究实施时间:

Study execute time:

From2020-05-29To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

右美剂量0.5μg/kg滴鼻

干预措施代码:

Intervention:

Nasal drops with dextromethorax 0.5μg/kg

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

等容量生理盐水滴鼻

干预措施代码:

Intervention:

Nasal drops with equal volume of normal saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽省合肥市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Hefei Maternal and Child Heath Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS pain score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇痛起效时间

指标类型:

主要指标 

Outcome:

Onset time of analgesia

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:

标本中文名:

脐带静脉血

组织:

Sample Name:

Umbilical venous 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 35 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由不知项目具体内容的麻醉医师采用随机数字表产生随机序列

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

Random number tables are used to generate random sequences by anesthesiologists who do not know the specific contents of the project.

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

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):

2020年12月31日,中国临床试验注册中心

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

2020/12/31,China clinical trial registry

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-29
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