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舒芬太尼联合罗哌卡因用于瘢痕子宫与非瘢痕子宫剖宫产术后镇痛效果比较
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注册号:

Registration number:

ChiCTR1900024442 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

舒芬太尼联合罗哌卡因用于瘢痕子宫与非瘢痕子宫剖宫产术后镇痛效果比较 

Public title:

Comparison of analgesic effect of sufentanil combined with ropivacaine for cesarean  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

互联网知识导入对二次剖宫产术后镇痛效果的影响 

Scientific title:

The influence of Internet knowledge introduction on analgesic effect after second cesarean section 

研究课题代号(代码):

Study subject ID:

 

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:

郑丽花 

研究负责人:

郑丽花 

Applicant:

Zheng Lihua 

Study leader:

Zheng Lihua 

申请注册联系人电话:

Applicant telephone:

+86 13205705553 

研究负责人电话:

Study leader's telephone:

+86 13205705553 

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:

qzzhenglh@163.com 

研究负责人电子邮件:

Study leader's E-mail:

qzzhenglh@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:

浙江省衢州市钟楼底2号 

研究负责人通讯地址:

浙江省衢州市钟楼底2号 

Applicant address:

2 Bell Tower, Quzhou, Zhejiang, China 

Study leader's address:

2 Bell Tower, Quzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

324000 

研究负责人邮政编码:

Study leader's postcode:

324000 

申请人所在单位:

浙江中医药大学附属衢州医院 

Applicant's institution:

Quzhou Hospital Affiliated to Zhejiang Chinese 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:

2018伦审(83) 

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:

衢州市人民医院伦理委员会 

Name of the ethic committee:

Quzhou City Ethics Committee of People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-07-16 

伦理委员会联系人:

占研 

Contact Name of the ethic committee:

Zhan Yan 

伦理委员会联系地址:

浙江省衢州市钟楼底2号 

Contact Address of the ethic committee:

2 Bell Tower, Quzhou, Zhejiang, 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:

浙江中医药大学附属衢州医院 

Primary sponsor:

Quzhou Hospital Affiliated to Zhejiang Chinese Medical University 

研究实施负责(组长)单位地址:

浙江省衢州市钟楼底2号 

Primary sponsor's address:

2 Bell Tower, Quzhou, Zhejiang, 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):

浙江省

市(区县):

衢州市

Country:

China

Province:

Zhejiang

City:

Quzhou

单位(医院):

浙江中医药大学附属衢州医院

具体地址:

钟楼底2号

Institution
hospital:

Quzhou Hospital Affiliated to Zhejiang Chinese Medical University

Address:

2 Bell Tower

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

剖宫产 

Target disease:

cesarean 

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:

其它 

Study phase:

N/A 

研究目的:

评价不同浓度的舒芬太尼联合罗哌卡因用于瘢痕子宫与非瘢痕子宫剖宫产术后镇痛的效果。 

Objectives of Study:

To evaluate the effects of different concentrations of sufentanil combined with ropivacaine on analgesia after cesarean section in scar uterus and non-scarred uterus. 

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:

ASA I~II 级拟行剖腹产的手术患者,肝肾功能正常。 

Inclusion criteria

Patients with ASA I to II who underwent caesarean section had normal liver and kidney function. 

排除标准:

1 年龄小于25岁或大于40岁; 2 身高低于150cm或高于170cm; 3 体重指数高于35kg/m2; 4 具有高血压及其他全身性疾病; 5 凝血异常; 6 有腰硬联合麻醉禁忌及镇痛用药禁忌; 7 双胎或多胎妊娠; 8 先兆子痫与妊高征等产科异常情况; 9 慢性疼痛或药物成瘾; 10 存在精神疾病。 

Exclusion criteria:

1 aged less than 25 years or older than 40 years; 2 height less than 150cm or higher than 170cm; 3 body mass index higher than 35kg/m2; 4 with hypertension and other system icdiseases; 5 coagulation abnormalities; 6 there are contraindications for spinal and epidural anesthesia and analgesic medication contraindications; 7 twin or multiple pregnancies; 8 pre-eclampsia and pregnancy-induced hypertension and other obstetric abnormalities; 9 chronic pain or drug addiction; 10 mental illness. 

研究实施时间:

Study execute time:

From2019-07-01To 2019-10-31 

干预措施:

Interventions:

组别:

非疤痕子宫产妇低浓度组

样本量:

20

Group:

Low concentration group of non-scar uterus parturients

Sample size:

干预措施:

0.5ug/mL 舒芬太尼

干预措施代码:

Intervention:

0.5ug/mL sufentanil

Intervention code:

组别:

非疤痕子宫产妇高浓度组

样本量:

20

Group:

High concentration group of non-scar uterus parturients

Sample size:

干预措施:

1ug/mL 舒芬太尼

干预措施代码:

Intervention:

1ug/mL sufentanil

Intervention code:

组别:

疤痕子宫产妇低浓度组

样本量:

20

Group:

Low concentration group of scar uterus parturients

Sample size:

干预措施:

0.5ug/mL 舒芬太尼

干预措施代码:

Intervention:

0.5ug/mL sufentanil

Intervention code:

组别:

疤痕子宫产妇高浓度组

样本量:

20

Group:

High concentration group of scar uterus parturients

Sample size:

干预措施:

1ug/mL 舒芬太尼

干预措施代码:

Intervention:

1ug/mL sufentanil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

衢州市 

Country:

China 

Province:

Zhejiang 

City:

Quzhou 

单位(医院):

浙江中医药大学附属衢州医院 

单位级别:

三级甲等 

Institution
hospital:

Quzhou Hospital Affiliated to Zhejiang Chinese Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

VAS

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24h镇痛泵实际进药量

指标类型:

次要指标 

Outcome:

24h analgesia pump actual dose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应

指标类型:

副作用指标 

Outcome:

Adverse reactions

Type:

Adverse events 

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 25 years
最大 Max age 40 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):

非试验人员操作SPSS软件产生随机数字。

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

Random number given from SPSS operated by those who do not take part in trials.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

试验结束后 6 个月内公开原始记录的数据和研究计划书,采用临床试验公共管理平台并向公众开放查询, http://www.medresman.org

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

In the six months after the trial, the data and research plan of the original record was published, and the public management platform was adopted and the inquiry was opened to the public.

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:

数据包括原始记录、病例记录表等,均遵从方案数据集及全分析数据集进行管理,并采用临床试验公共平台管理。

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

The data includes the original record, case record, etc., which is managed by the Per Protocol Set and the Full Analysis Set, and is managed by the clinical trial public platform.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-12
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