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Sleep quality affects early recovery following total hip arthroplasty, A Randomized, Double-blind, Controlled Trail
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注册号:

Registration number:

ChiCTR-IOR-16007861 

最近更新日期:

Date of Last Refreshed on:

2016-01-30 

注册时间:

Date of Registration:

2016-01-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

睡眠质量影响全髋关节置换术后早期功能恢复 

Public title:

Sleep quality affects early recovery following total hip arthroplasty, A Randomized, Double-blind, Controlled Trail 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

睡眠质量影响全髋关节置换术后早期功能恢复 

Scientific title:

Sleep quality affects early recovery following total hip arthroplasty, A Randomized, Double-blind, Controlled Trail 

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:

王端 

研究负责人:

周宗科 

Applicant:

Wang Duan 

Study leader:

Zhou Zongke 

申请注册联系人电话:

Applicant telephone:

+86 15608049924 

研究负责人电话:

Study leader's telephone:

+86 18980601028 

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:

wangduan_bone@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zongke@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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China  

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院骨科 

Applicant's institution:

Department of Orthopaedics, West China Hospital, Sichuan 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:

2012年审 (268)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:

四川大学华西医院临床试验与生物医学伦理专委会  

Name of the ethic committee:

Clinical Research and Biomedical Ethical Committee of West China hospital, Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-01-07 

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:

四川大学华西医院骨科 

Primary sponsor:

Department of Orthopaedics, West China Hospital, Sichuan University  

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

卫生部行业科研专项基金 

Source(s) of funding:

Ministry of Health Special Scientific Research Projects of China  

研究疾病:

膝关节骨关节炎;类风湿性骨关节炎 

Target disease:

Knee osteoartritis;Rheumatoid arthritis  

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:

评价全髋关节置换术后常规应用小剂量唑吡坦改善睡眠质量的安全性和有效性  

Objectives of Study:

To evaluate the safety and effectiveness of low-dose zolpidem for a short time after total hip arthroplasty  

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:

①初次、单侧全膝关节置换术;②膝关节骨关节炎或膝关节类风湿性关节炎的患者;③能够并愿意签署知情同意书  

Inclusion criteria

1. Primary unilateral total knee artropasty; 2. Patients with Knee osteoartritis or Rheumatoid arthritis; 3. Able and willing to provide signed informed consent.  

排除标准:

1.双膝关节一期手术或膝关节翻修术; 2.膝关节既往手术史; 3.近三月内做过膝关节穿刺; 4.膝关节僵直; 5.血液凝固障碍性疾病; 6.下肢深静脉血栓病史; 7.无法控制的高血压、严重的心血管疾病、心衰、慢性阻塞性肺炎、肝肾衰竭等严重的伴随疾病 ; 8.对非甾体抗炎药、口服镇痛药及唑吡坦敏感的患者; 9.睡眠呼吸暂停综合症、抑郁症、老年痴呆、帕金森病史; 10.应用镇静剂或催眠药物 11.不能进行多导睡眠图测量 

Exclusion criteria:

1. Simultaneously bilateral total knee artropasty or revision case; 2. Surgical History of the knee joint; 3. Knee joint cavity paracentesis in recent 3 months; 4. Stiffness with knee; 5. Blood coagulation disorders; 6. History of deep venous thrombosis; 7. Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure 8. allergic to NSAIDs, opioid analgesics, zolpidem 9. sleep apnea, Parkinson disease, dementia, depression 10. use of sedatives or hypnotics 11.inability to comply with polysomnographic measurement 

研究实施时间:

Study execute time:

From2016-02-02To 2016-05-04 

干预措施:

Interventions:

组别:

试验组

样本量:

85

Group:

Experimental group

Sample size:

干预措施:

睡眠药物

干预措施代码:

Intervention:

hypnotics

Intervention code:

组别:

对照组

样本量:

85

Group:

Controlled group

Sample size:

干预措施:

不服用安眠药物

干预措施代码:

Intervention:

no hypnotics

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

输血量

指标类型:

次要指标 

Outcome:

Blood transfusion volume

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血率

指标类型:

次要指标 

Outcome:

Blood transfusion cases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白量

指标类型:

次要指标 

Outcome:

Hb

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞压积

指标类型:

次要指标 

Outcome:

Hct

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伤口辅料更换次数

指标类型:

次要指标 

Outcome:

Dressing change

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋关节活动度

指标类型:

主要指标 

Outcome:

Range of motion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋关节评分

指标类型:

次要指标 

Outcome:

KSS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟疼痛评分

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:

视觉模拟满意度评分

指标类型:

次要指标 

Outcome:

VAS satisfaction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肢体周径增加

指标类型:

次要指标 

Outcome:

Swelling

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

股四头肌肌力

指标类型:

次要指标 

Outcome:

Quadriceps strength

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉

指标类型:

次要指标 

Outcome:

ESR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

次要指标 

Outcome:

SF-12

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多导睡眠图测量

指标类型:

主要指标 

Outcome:

polysomnographic measurement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失眠严重指数

指标类型:

主要指标 

Outcome:

Insomnia severity index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

主要指标 

Outcome:

PSQI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

广泛焦虑量表

指标类型:

主要指标 

Outcome:

GAD-7

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

WOMAC评分

指标类型:

主要指标 

Outcome:

WOMAC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 88 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):

由工作人员运用电脑随机数字产生随机序列

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

Using computer-generated random number table to generate a random sequence by worker

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

华西医院

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

West China Hospital

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:

 2016-01-30
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