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黄静霞医师: 该研究的伦理审批文件未上传,请尽快上传。 斜视矫正术后疼痛原因分析及防治策略
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注册号:

Registration number:

ChiCTR1900023799 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

黄静霞医师: 该研究的伦理审批文件未上传,请尽快上传。 斜视矫正术后疼痛原因分析及防治策略 

Public title:

Cause analysis and prevention strategy of postoperative pain after strabismus surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

斜视矫正术后疼痛原因分析及防治策略 

Scientific title:

Cause analysis and prevention strategy of postoperative pain after strabismus surgery 

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:

黄静霞 

研究负责人:

黄静霞 

Applicant:

Jingxia Huang 

Study leader:

Jingxia Huang 

申请注册联系人电话:

Applicant telephone:

+86 13694217880 

研究负责人电话:

Study leader's telephone:

+86 13694217880 

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:

13694217880@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13694217880@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:

广州市越秀区先烈南路54号 

研究负责人通讯地址:

广州市越秀区先烈南路54号 

Applicant address:

54 Xianlie Road South, Yuexiu District, Guangzhou 

Study leader's address:

54 Xianlie Road South, Yuexiu District, Guangzhou 

申请注册联系人邮政编码:

Applicant postcode:

510060 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中山大学中山眼科中心麻醉科 

Applicant's institution:

Department of Anesthesiology, Zhongshan Ophthalmology Center, Sun Yat-Sen 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:

2019KYPJ056 

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:

中山大学中山眼科中心医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Zhongshan Ophthalmology Center, Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

颜彦杰 

Contact Name of the ethic committee:

Yanjie Yan 

伦理委员会联系地址:

广州市越秀区先烈南路54号 

Contact Address of the ethic committee:

54 Xianlie Road South, Yuexiu District, Guangzhou 

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:

中山大学中山眼科中心 

Primary sponsor:

Department of Anesthesiology, Zhongshan Ophthalmology Center, Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市越秀区先烈南路54号 

Primary sponsor's address:

54 Xianlie Road South, Yuexiu District, Guangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学中山眼科中心

具体地址:

越秀区先烈南路54号

Institution
hospital:

Zhongshan Ophthalmology Center, Sun Yat-Sen University

Address:

54 Xianlie Road South, Yuexiu District

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

斜视 

Target disease:

strabismus 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

① 探讨斜视矫正术后疼痛及术后不适的原因及危险因素; ② 探讨一种安全有效的眼科术后疼痛管理的临床路径。 

Objectives of Study:

1.To investigate the causes and risk factors of postoperative pain and discomfort after strabismus surgery; 2.To explore a safe and effective clinical approach for pain management after ophthalmology surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

①16-65岁; ②全麻下行斜视矫正手术; ③签署知情同意书。 

Inclusion criteria

1.aged 16 to 65 years old; 2.the use of general anesthesia for strabismus surgery; 3.Signing informed consent. 

排除标准:

①任何无法控制的临床问题(如严重的精神、神经、心血管、呼吸等系统疾 病以及其他恶性肿瘤); ②研究者认为需要排除者。 

Exclusion criteria:

1.any uncontrollable clinical problems (such as serious mental, neurological, cardiovascular, respiratory and other diseases and other malignant tumors); 2.the researchers think that the need to exclude 

研究实施时间:

Study execute time:

From2019-06-24To 2019-12-24 

干预措施:

Interventions:

组别:

暴露组+非暴露组

样本量:

210

Group:

exposure group + non-exposure group

Sample size:

干预措施:

干预措施代码:

Intervention:

no intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学中山眼科中心 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan Ophthalmology Center, Sun Yat-Sen University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

术后疼痛评分

指标类型:

主要指标 

Outcome:

postoperative pain scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

次要指标 

Outcome:

Self-rating Anxiety Scale, SAS

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:

组织:

Sample Name:

No sample

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 16 years
最大 Max age 65 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):

未使用

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

Not used

盲法:

N/A

Blinding:

N/A

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):

邮箱

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

mailbox

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:

纸质版试验数据记录表和电子版excel表格

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

Test data records and excel dataset

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-12
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