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术中应用小剂量右旋美托咪定和利多卡因对开颅小儿神经外科后疼痛的随机双盲对照研究
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注册号:

Registration number:

ChiCTR1800019411 

最近更新日期:

Date of Last Refreshed on:

2019-07-21 

注册时间:

Date of Registration:

2018-11-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

术中应用小剂量右旋美托咪定和利多卡因对开颅小儿神经外科后疼痛的随机双盲对照研究 

Public title:

A randomized double-blind controlled trial for low-dose dexmetidine and lidocaine in the treatment of post-craniotomy pain in children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术中应用小剂量右旋美托咪定和利多卡因对开颅小儿神经外科后疼痛的随机双盲对照研究 

Scientific title:

A randomized double-blind controlled trial for low-dose dexmetidine and lidocaine in the treatment of post-craniotomy pain in children 

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:

李璐 

研究负责人:

金旭 

Applicant:

Lu Li 

Study leader:

Xu Jin 

申请注册联系人电话:

Applicant telephone:

+86 18086960385 

研究负责人电话:

Study leader's telephone:

+86 13693336261 

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:

18228252220@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xiehe2000@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:

北京市丰台区南四环西路119号 

研究负责人通讯地址:

北京市丰台区南四环西路119号 

Applicant address:

119 South Fourth Ring Road West, Fengtai District, Beijing, China 

Study leader's address:

119 South Fourth Ring Road West, Fengtai District, Beijing, 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:

首都医科大学附属北京天坛医院 

Applicant's institution:

Beijing Tiantan Hospital, Capital 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:

KY 2018-087-02 

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:

首都医科大学附属北京天坛医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Tiantan Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-13 

伦理委员会联系人:

宋茂民 

Contact Name of the ethic committee:

Maomin Song 

伦理委员会联系地址:

北京市丰台区南四环西路119号 

Contact Address of the ethic committee:

119 South Fourth Ring Road West, Fengtai District, Beijing, 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:

首都医科大学附属北京天坛医院 

Primary sponsor:

Beijing Tiantan Hospital, Capital Medical University  

研究实施负责(组长)单位地址:

北京市丰台区南四环西路119号 

Primary sponsor's address:

119 South Fourth Ring Road West, Fengtai District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京天坛医院

具体地址:

丰台区南四环西路119号

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University

Address:

119 South Fourth Ring Road West, Fengtai District

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

小儿神经外科术后疼痛 

Target disease:

Postoperative pain in pediatric neurosurgery  

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

本研究旨在比较术中小剂量使用右旋美托咪定和利多卡因分别对小儿神外开颅术后的疼痛的影响,以求寻找到更佳的治疗方案,从而减少或减轻术后疼痛的发生,惠及更多儿童。 

Objectives of Study:

This study aims to compare the effects of low dose dexmetomidine and lidocaine on postoperative pain in children after craniotomy. In order to find a better treatment to reduce the incidence of postoperative pain and benefit more children. 

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)年龄1-12岁; 2)ASA 1-3级; 3)择期开颅手术肿瘤切除的患儿; 4)患者或其监护人已签署知情同意书。 

Inclusion criteria

1) Aged 1-12 years old; 2) ASA 1-3; 3) Children with craniotomy; 4) Informed consent signed by the patient or his guardian. 

排除标准:

1)心理疾患; 2)气道异常、反应性气道疾病; 3)术后不能拔除气管插管的患儿; 4)手术后3天血肿或严重脑水肿行第二次手术的患儿; 5)正在参加其它临床试验的患者 

Exclusion criteria:

1) Psychological disorders; 2) Airway abnormality; 3) Children who cannot remove tracheal incubation after operation; 4) Children with hematoma or severe cerebral edema who require a second operation 3 days after operation; 5) Patients participating in other clinical trials. 

研究实施时间:

Study execute time:

From2018-12-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2018-12-01To  

干预措施:

Interventions:

组别:

右旋美托咪定组

样本量:

85

Group:

Group 1

Sample size:

干预措施:

静脉泵注右旋美托咪定

干预措施代码:

Intervention:

Intravenous injection of dexmetidine

Intervention code:

组别:

利多卡因组

样本量:

85

Group:

Group 2

Sample size:

干预措施:

静脉泵注利多卡因

干预措施代码:

Intervention:

Intravenous injection of lidocaine

Intervention code:

组别:

生理盐水组

样本量:

85

Group:

Group 3

Sample size:

干预措施:

静脉泵注生理盐水

干预措施代码:

Intervention:

Intravenous injection of saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京天坛医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital  

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 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:

镇痛剂使用情况

指标类型:

主要指标 

Outcome:

use of analgesics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇痛泵安全性评价

指标类型:

主要指标 

Outcome:

safety evaluation of analgesic pump

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患儿一般情况

指标类型:

次要指标 

Outcome:

general situation of children

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症

指标类型:

次要指标 

Outcome:

postoperative complications

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

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 12 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):

由特定研究人员采用随机数字法

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

Use of the method of random number by specific researchers

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

论文发表后,以论文形式共享

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

After the publication of the paper, it is shared in the form of a paper

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:

病例记录表、电子采集和管理系统

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

CRF and EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-11-10
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