今天是:2019-10-22 星期二

硫酸镁用于糖尿病足术后镇痛
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-14004944 

最近更新日期:

Date of Last Refreshed on:

2016-06-17 

注册时间:

Date of Registration:

2014-07-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

硫酸镁用于糖尿病足术后镇痛 

Public title:

Magnesium for the postoperative analgesia of DM feet amputation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硫酸镁的围术期术后镇痛 

Scientific title:

Magnesium sulphate is used for perioperative analgesia 

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:

孙捷豪 

研究负责人:

孙捷豪 

Applicant:

Jiehao Sun 

Study leader:

Jiehao Sun 

申请注册联系人电话:

Applicant telephone:

+86 13676721930 

研究负责人电话:

Study leader's telephone:

+86 13676721930 

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:

sun_jiehao@126.com 

研究负责人电子邮件:

Study leader's E-mail:

sun_jiehao@126.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:

温州医科大学附属第一医院麻醉科 

研究负责人通讯地址:

温州医科大学附属第一医院麻醉科 

Applicant address:

Department of anesthesiology, 1st Affiliated Hospital of Wenzhou Medical University 

Study leader's address:

Department of anesthesiology, 1st Affiliated Hospital of Wenzhou Medical University 

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:

温州医科大学附属第一医院麻醉科 

Applicant's institution:

1st Affiliated Hospital of Wenzhou 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:

2014-34 

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:

温州医科大学附属第一医院 

Name of the ethic committee:

1st Affiliated Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-06-26 

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:

温州医科大学附属第一医院麻醉科 

Primary sponsor:

1st Affiliated Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市瓯海区南白象上蔡村1号 

Primary sponsor's address:

1 Shangcai viliage, Baixiang South, Ouhao district, Wenzhou, 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

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属第一医院

具体地址:

浙江省温州市瓯海区南白象上蔡村1号

Institution
hospital:

1st Affiliated Hospital of Wenzhou Medical University

Address:

1 Shangcai viliage, Baixiang South, Ouhao district, Wenzhou, Zhejiang, China

经费或物资来源:

None 

Source(s) of funding:

none 

研究疾病:

糖尿病足截指 

Target disease:

DM feet amputation 

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:

上市后药物 

Study phase:

研究目的:

研究硫酸镁能抑制NMDA受体,减少局部组织的炎症反应,减少炎症因子释放,减少痛觉的中枢型敏化 

Objectives of Study:

Magnesium sulphate inhibite the NMDA receptor and decrease local inflammation and inhibite central sensitization. 

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:

糖尿病足患者行截趾手术 

Inclusion criteria

DM feet patients perform amputation surgery 

排除标准:

听觉、视觉障碍;精神疾病史;长期服用镇静剂;嗜酒、吸毒史;预期生存率小于12个月;心力衰竭,EF小于等于30%,或6个月内因心力衰竭入院者;12个月内有中风史;既往12个月内有严重的出血史;对硫酸镁或利多卡因过敏 

Exclusion criteria:

Deaf, blind; psychological disorder; sedative abuse; opioid abuse; alcohol abuse; congestive heart failure; EF less than 30%; expected survival period shorter than 6 months; stroke within 12 months; severe bleeding within 12 months; allergic to lidocaine or sulphate. 

研究实施时间:

Study execute time:

From2014-07-15To 2014-10-30 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

0.25%罗哌卡因15ml

干预措施代码:

Intervention:

0.25% ropivacaine 15ml

Intervention code:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

0.25%罗哌卡因15ml+硫酸镁200mg

干预措施代码:

Intervention:

0.25% ropivacaine 15ml and 200mg MgSO4

Intervention code:

组别:

3

样本量:

30

Group:

3

Sample size:

干预措施:

0.375%罗哌卡因15ml

干预措施代码:

Intervention:

0.375% ropivacaine 15ml

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):

温州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

1st affiliated hospital of wenzhou medical university  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后各时间点疼痛vas评分

指标类型:

主要指标 

Outcome:

postoperative 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:

术后首次镇痛时间

指标类型:

主要指标 

Outcome:

postoperative rescue analgesia time

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24小时内啡肽

指标类型:

次要指标 

Outcome:

postoperative 24h of b-endophine

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 50 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

设计者计算机随机后信封密闭

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

designer used computerized randomization and sealed envelop

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:

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):

NA

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

NA

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-07-11
返回列表