今天是:2020-08-11 星期二

头皮神经阻滞用于开颅小儿神经外科镇痛的研究
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注册号:

Registration number:

ChiCTR1800017386 

最近更新日期:

Date of Last Refreshed on:

2020-04-26 

注册时间:

Date of Registration:

2018-07-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

头皮神经阻滞用于开颅小儿神经外科镇痛的研究 

Public title:

A study of scalp nerve block for neurosurgical analgesia in children with craniotomy  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

头皮神经阻滞用于开颅小儿神经外科镇痛的研究 

Scientific title:

A study of scalp nerve block for neurosurgical analgesia in children with craniotomy  

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:

中国北京市首都医科大学附属北京天坛医院麻醉科 

研究负责人通讯地址:

中国北京市首都医科大学附属北京天坛医院麻醉科 

Applicant address:

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China 

Study leader's address:

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, 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 2018-078-02 

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:

2018-08-23 

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:

中国北京市首都医科大学附属北京天坛医院 

Contact Address of the ethic committee:

Beijing Tiantan Hospital, Capital Medical University, 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:

中国北京市首都医科大学附属北京天坛医院麻醉科 

Primary sponsor's address:

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, 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:

中国北京市首都医科大学附属北京天坛医院麻醉科

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University

Address:

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China

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:

研究头皮神经阻滞对开颅小儿神经外科术后疼痛的影响 

Objectives of Study:

Effect of scalp nerve block on postoperative pain in children undergoing craniotomy 

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)开颅肿瘤切除术的患儿;4)18 kg/m2

Inclusion criteria

1) Aged 1-12 years; 2) ASA 1-3; 3) Children with craniotomy tumor resection; 4)18 kg/m2

排除标准:

1)合并严重疾患及心功能不全的患者;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)肝肾功能异常(ALT、AST、BUN、Cr 超出正常值1.5倍)者;5)正在参加其它临床试验的患者;6)父母不能或不愿提供知情同意或依从性差的患儿;7)具有精神疾病或者使用抗精神病药物进行治疗者;8)后正中开颅手术 

Exclusion criteria:

1)Children with severe diseases or cardiac insufficiency; 2)Airway abnormalities and reactive airway diseases; 3)Children who色 cannot be removed from the endotracheal intubation after surgery; 4)Children with abnormal liver and kidney function (ALT, AST, BUN, Cr is 1.5 times higher than normal value); 5)Children who have participated in other clinical trials; 6)Chikdren whose parents are Unable or unwilling to provide informed consent or poor compliance; 7)Children who have mental illness or use antipsychotic drugs for treatment; 8)Posterior fossa craniotomy for tumor. 

研究实施时间:

Study execute time:

From2018-09-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2018-09-13To 2020-10-31 

干预措施:

Interventions:

组别:

术前罗哌卡因阻滞组(小儿)

样本量:

30

Group:

Younger children group 1

Sample size:

干预措施:

术前罗哌卡因阻滞

干预措施代码:

Intervention:

Preoperative nerve block with ropivacaine

Intervention code:

组别:

术后罗哌卡因阻滞组(小儿)

样本量:

30

Group:

Younger children group 2

Sample size:

干预措施:

术后罗哌卡因阻滞

干预措施代码:

Intervention:

Postoperative nerve block with ropivacaine

Intervention code:

组别:

非阻滞对照组(小儿)

样本量:

30

Group:

Younger children control group

Sample size:

干预措施:

无干预措施

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

术前罗哌卡因阻滞组(大儿)

样本量:

30

Group:

Older children group 1

Sample size:

干预措施:

术前罗哌卡因阻滞

干预措施代码:

Intervention:

Preoperative nerve block with ropivacaine

Intervention code:

组别:

术后罗哌卡因阻滞组(大儿)

样本量:

30

Group:

Older children group 2

Sample size:

干预措施:

术后罗哌卡因阻滞

干预措施代码:

Intervention:

Postoperative nerve block with ropivacaine

Intervention code:

组别:

非阻滞对照组(大儿)

样本量:

30

Group:

Older children control group

Sample size:

干预措施:

无干预措施

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):

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):

患儿按照自然年龄开放式进入小小儿(1-6岁)组和大儿组(7-12岁)组,然后再采用随机数字法进行随机分组,分为术前罗哌卡因阻滞组、术后罗哌卡因阻滞组和非阻滞对照组。

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

According to the natural age, the children entered the younger children (1-6 years old) group and the older children group (7-12 years old). Then they were randomly divided into preoperative ropivacaine block group, postoperative ropivacaine block group and control group without ropivacaine.

盲法:

Not stated

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):

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):

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-07-27
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