今天是:2019-10-22 星期二

鞘内添加硫酸镁对布比卡因腰麻剖宫产的量效关系的影响
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-14004954 

最近更新日期:

Date of Last Refreshed on:

2015-09-02 

注册时间:

Date of Registration:

2014-07-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

鞘内添加硫酸镁对布比卡因腰麻剖宫产的量效关系的影响 

Public title:

The effect on dose-response of adding magnesium to intrathecal bupivacaine for spinal anesthesia in cesarean section 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

鞘内添加硫酸镁对布比卡因腰麻剖宫产的量效关系的影响 

Scientific title:

The effect on dose-response of adding magnesium to intrathecal bupivacaine for spinal anesthesia in 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:

肖飞 

研究负责人:

肖飞,陈新忠 

Applicant:

FEI XIAO 

Study leader:

Fei Xiao, Xinzhong, Chen 

申请注册联系人电话:

Applicant telephone:

+86 13706597501 

研究负责人电话:

Study leader's telephone:

+86 13706597501 

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:

1036230359@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1036230359@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:

浙江省嘉兴市妇幼保健院麻醉科 

研究负责人通讯地址:

浙江省嘉兴市妇幼保健院麻醉科, 浙江大学医学院附属妇产科医院 

Applicant address:

Department of Anesthesia, Jiaxing Maternity and Child Care Hospital, Jiaxing, Zhejiang, China 

Study leader's address:

Department of Anesthesia, Jiaxing Maternity and Child Care Hospital; Zhejiang University Medical Collage, Women's Hospital 

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:

浙江省嘉兴市妇幼保健院, 浙江大学医学院附属妇产科医院 

Applicant's institution:

Jiaxing Maternity and Child Care Hospital; Zhejiang University Medical Collage, Women's 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:

20140029 

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:

浙江大学医学院附属妇产科医院医学伦理委员会 

Name of the ethic committee:

Zhejiang University Medical Collage, Women's Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-07-21 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

浙江大学医学院附属妇产科医院 

Primary sponsor:

Zhejiang University Medical Collage, Women's Hospital Medical 

研究实施负责(组长)单位地址:

浙江省嘉兴市妇幼保健院, 浙江大学医学院附属妇产科医院 

Primary sponsor's address:

Jiaxing Maternity and Child Care Hospital; Zhejiang University Medical Collage, Women's Hospital 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

医院提供 

Source(s) of funding:

support by our hospital 

研究疾病:

剖宫产 

Target disease:

cesarean section 

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:

观察鞘内添加硫酸镁能否降低剖宫产腰麻布比卡因的需要量。 

Objectives of Study:

This study aimed to explore whether the addition of magnesium can reduce intrathecal dose requirement of bupivacaine. 

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:

单胎、足月(37w-40w)、初产,ASA I级或Ⅱ级 

Inclusion criteria

single birth, mature (37w-40w), primiparty, ASA I-III 

排除标准:

椎管内禁忌症、胎儿窘迫、产妇有内科合并症 

Exclusion criteria:

Spinal canal contraindications, fetal distress, maternal medical complications. 

研究实施时间:

Study execute time:

From2014-09-01To 2014-12-31 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

硫酸镁+布比卡因

干预措施代码:

Intervention:

Magnesium sulfate + bupivacaine

Intervention code:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

布比卡因

干预措施代码:

Intervention:

bupivacaine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

嘉兴市妇保院 

单位级别:

市级 

Institution
hospital:

Jiaxing Maternity and Child Care Hospital  

Level of the institution:

municipal 

测量指标:

Outcomes:

指标中文名:

布比卡因半数有效量

指标类型:

主要指标 

Outcome:

THE ED50 OF BUPIVACAINE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感觉阻滞起效时间

指标类型:

主要指标 

Outcome:

the onset of sensory block

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感觉阻滞维持时间

指标类型:

主要指标 

Outcome:

the duration of sensory block

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感觉阻滞维持时间

指标类型:

主要指标 

Outcome:

the recovery of sensory block

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动阻滞起效时间

指标类型:

主要指标 

Outcome:

the onset of motor block

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动阻滞维持时间

指标类型:

主要指标 

Outcome:

the duration of motor block

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动阻滞恢复时间

指标类型:

主要指标 

Outcome:

the recovery of motor block

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

麻醉维持时间

指标类型:

主要指标 

Outcome:

duration of spinal anaesthesia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS SCOR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后镇痛药的需要量

指标类型:

次要指标 

Outcome:

the requiement of postoperative analgesia

Type:

Secondary 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:

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 25 years
最大 Max age 30 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):

入选后,由计算机随机产生顺序1-60号,并且放入密闭的信封中,随机抽取分成两组。

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

After enrollment, patients were randomized by means of blinded opaque envelopes that had been sorted

盲法:

Blinding:

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:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-07-15
返回列表