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Analgesic effect of fentanyl combined with dexmedetomidine and parexib sodium in wound dressing change
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注册号:

Registration number:

ChiCTR1900027965 

最近更新日期:

Date of Last Refreshed on:

2020-08-06 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

芬太尼联合右美托咪定、帕瑞昔布钠在创面换药中的镇痛效果研究 

Public title:

Analgesic effect of fentanyl combined with dexmedetomidine and parexib sodium in wound dressing change 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

芬太尼联合右美托咪定、帕瑞昔布钠在创面换药中的镇痛效果研究 

Scientific title:

Analgesic effect of fentanyl combined with dexmedetomidine and parexib sodium in wound dressing change 

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:

谭晶洁 

研究负责人:

黄广涛 

Applicant:

Jingjie Tan 

Study leader:

Guangtao Huang 

申请注册联系人电话:

Applicant telephone:

+86 18311544208 

研究负责人电话:

Study leader's telephone:

+86 18085287828 

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:

tanjj0905@163.com 

研究负责人电子邮件:

Study leader's E-mail:

haitao3140@sina.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:

贵州省遵义市大连路149号 

研究负责人通讯地址:

贵州省遵义市大连路149号 

Applicant address:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, China 

Study leader's address:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, 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:

遵义医科大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Zunyi 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:

2018-10 

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:

遵义医科大学第一附属医院医疗技术应用伦理委员会 

Name of the ethic committee:

Medical Technique Application Ethics Committee of The First Affiliated Hospital of Zunyi Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-25 

伦理委员会联系人:

遵义医科大学第一附属医院医疗技术应用伦理委员会 

Contact Name of the ethic committee:

Medical Technique Application Ethics Committee of The First Affiliated Hospital of Zunyi Medical University 

伦理委员会联系地址:

贵州省遵义市大连路149号 

Contact Address of the ethic committee:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, 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:

遵义医科大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Zunyi Medical University 

研究实施负责(组长)单位地址:

贵州省遵义市大连路149号 

Primary sponsor's address:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, 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):

贵州省

市(区县):

遵义市

Country:

China

Province:

Guizhou

City:

Zunyi

单位(医院):

遵义医科大学附属医院

具体地址:

大连路149号

Institution
hospital:

The First Affiliated Hospital of Zunyi Medical University

Address:

149 Dalian Road, Huichuan District

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

烧伤 

Target disease:

Burn 

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:

探索性研究/预试验 

Study phase:

研究目的:

一、探索单独使用芬太尼对创面换药镇痛效果的疗效; 二、探索芬太尼联合右美托咪定对创面换药镇痛效果的疗效; 三、探索芬太尼联合右美托咪定、帕瑞昔布钠对创面换药镇痛效果的疗效。 

Objectives of Study:

1. To explore the effect of fentanyl alone on the analgesic effect of wound dressing change; 2. To explore the effect of fentanyl combined with dexmedetomidine on the analgesic effect of wound dressing change; 3. To explore the effect of fentanyl combined with dexmedetomidine and parexib sodium on the analgesic effect of wound dressing change. 

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:

年龄:18-65岁之间 创伤面积:>5% 

Inclusion criteria

Aged between 18 and 65 years; Wound area: > 5% 

排除标准:

心率低于60次/分; 血压低于90/60mmHg; 镇痛镇静药物过敏; 合并颅脑疾患; 心率失常、传导阻滞; 慢性呼吸道疾病,慢性缺氧。 

Exclusion criteria:

Heart rate below 60 beats/min; Blood pressure below 90/60mmhg; Allergy to analgesics and sedatives; Concomitant craniocerebral disease; Arrhythmia, conduction block; Chronic respiratory disease, chronic hypoxia. 

研究实施时间:

Study execute time:

From2019-12-06To 2020-12-06 

征募观察对象时间:

Recruiting time:

From2019-12-06To 2020-12-01 

干预措施:

Interventions:

组别:

A

样本量:

22

Group:

A

Sample size:

干预措施:

芬太尼

干预措施代码:

Intervention:

fentanyl

Intervention code:

组别:

B

样本量:

22

Group:

B

Sample size:

干预措施:

芬太尼+右美托咪定

干预措施代码:

Intervention:

Fentanyl combined with dexmedetomidine

Intervention code:

组别:

C

样本量:

22

Group:

C

Sample size:

干预措施:

芬太尼+右美托咪定+帕瑞昔布钠

干预措施代码:

Intervention:

fentanyl combined with dexmedetomidine and parexib sodium

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

贵州省 

市(区县):

遵义市 

Country:

China 

Province:

Guizhou 

City:

Zunyi 

单位(医院):

遵义医科大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Zunyi Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

换药前1h、0h;换药时;换药后10min,1h

测量方法:

Measure time point of outcome:

1h, 0h before dressing change; When dressing change; After dressing change 10min, 1h

Measure method:

指标中文名:

镇静评分

指标类型:

主要指标 

Outcome:

RASS

Type:

Primary indicator 

测量时间点:

换药前1h、0h;换药开始10min;换药后10min,1h

测量方法:

Measure time point of outcome:

1h, 0h before dressing change; When dressing change; After dressing change 10min, 1h

Measure method:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

换药前1h、0h;换药开始10min;换药后10min,1h

测量方法:

心电监测

Measure time point of outcome:

1h, 0h before dressing change; When dressing change; After dressing change 10min, 1h

Measure method:

electrocardiogram monitoring

指标中文名:

脉搏

指标类型:

主要指标 

Outcome:

electrocardiogram monitoring

Type:

Primary indicator 

测量时间点:

换药前1h、0h;换药开始10min;换药后10min,1h

测量方法:

心电监测

Measure time point of outcome:

1h, 0h before dressing change; When dressing change; After dressing change 10min, 1h

Measure method:

electrocardiogram monitoring

指标中文名:

呼吸

指标类型:

主要指标 

Outcome:

Breathe

Type:

Primary indicator 

测量时间点:

换药前1h、0h;换药开始10min;换药后10min,1h

测量方法:

心电监测

Measure time point of outcome:

1h, 0h before dressing change; When dressing change; After dressing change 10min, 1h

Measure method:

electrocardiogram monitoring

指标中文名:

血氧饱和度

指标类型:

主要指标 

Outcome:

oxyhemoglobin saturation

Type:

Primary indicator 

测量时间点:

换药前1h、0h;换药开始10min;换药后10min,1h

测量方法:

心电监测

Measure time point of outcome:

1h, 0h before dressing change; When dressing change; After dressing change 10min, 1h

Measure method:

electrocardiogram monitoring

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 18 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):

研究者;excel软件中随机公式:randbetween。

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

The researcher; The formula 'randbetween' of excel sofeware.

盲法:

对医务人员不设置盲法,仅对受试者及其余研究人员设置盲法。

Blinding:

Blind method for subjects and the rest of researchers (except medical staff).

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:

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):

临床试验公共管理平台, http://www.medresman.org.cn.

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

ResMan, http://www.medresman.org.cn.

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:

纸质版数据保存在临床科室,并全部及时上传至resman系统。

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

All the IPD were uploaded to resman system in time.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-12-07
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