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小剂量镇静药可加重局部神经功能缺陷
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注册号:

Registration number:

ChiCTR-TRC-13003774 

最近更新日期:

Date of Last Refreshed on:

2015-07-24 

注册时间:

Date of Registration:

2013-10-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

小剂量镇静药可加重局部神经功能缺陷 

Public title:

Small doses of Sedatives May Exacerbate Focal Neurologic Deficits 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

小剂量镇静药可加重局部神经功能缺陷 

Scientific title:

Small doses of Sedatives May Exacerbate Focal Neurologic Deficits 

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:

林楠 

研究负责人:

Adrian Gelb 

Applicant:

Nan Lin 

Study leader:

Adrian Gelb 

申请注册联系人电话:

Applicant telephone:

+86 13810108927 

研究负责人电话:

Study leader's telephone:

+1 415 476-0121 

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:

linnan127@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

gelba@anesthesia.ucsf.edu 

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:

北京市东城区天坛西里6号,麻醉科 

研究负责人通讯地址:

521 Parnassus Ave, C450, San Francisco, CA94143 

Applicant address:

No.6 Tiantan Xili, Anesthesia Dept., Dongcheng District, Beijing 

Study leader's address:

521 Parnassus Ave, C450, San Francisco, CA94143 

申请注册联系人邮政编码:

Applicant postcode:

100050 

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:

kylw-2010-017-02 

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:

首都医科大学附属北京天坛医院伦理委员会 

Name of the ethic committee:

IRB of Beijing Tiantan Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-12-20 

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:

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:

北京市东城区天坛西里6号,麻醉科 

Primary sponsor's address:

No.6 Tiantan Xili, Anesthesia Dept., Dongcheng District, Beijing 

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:

北京

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University

Address:

Beijing

经费或物资来源:

首都医科大学 

Source(s) of funding:

Capital Medical University 

研究疾病:

颅脑幕上肿瘤 

Target disease:

Supratentorial Tumor 

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:

I期临床试验 

Study phase:

研究目的:

目前,不同镇静机制对于神经功能的影响还不清楚。我们希望通过本项前瞻性研究,寻找到最适合神经外科手术的镇静药物,使其能够既保证充分的镇静,同时尽量降低对于神经功能评估的影响。通过对颅内肿瘤患者使用不同镇静机制的镇静药物,来探讨临床中出现的难以解释的神经症状和缺陷。此外,还希望通过此项研究来提供唤醒开颅和神经重症监护病房的最佳镇静药物选择。 

Objectives of Study:

From the current knowledge, the effect on neurological function by the sedative mechanism is still unclear. With the help of this perspective study, we hope to find the optimal sedative drugs using in neurosurgical operation to provide the adequate sedation as well as minimize the disturbing on postoperative neurological function evaluation. With the understanding of the different mechanism of those drugs on the intracranial lesion patients, we are trying to explain some unexpected clinical neurological symptoms and deficits. Besides, we are also trying to provide the optional sedative drugs using in awake-craniotomy procedure and neuronal intensive care unit. 

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:

幕上占位患者 (额-顶-颞部); 择期开颅手术患者; 18岁≤年龄≤65岁的患者; ASA I~II级的患者; 前述知情同意书的患者 

Inclusion criteria

Supratentorial mass lesion (frontal-parietal-temporal regions); Elective craniotomy; Aged 18 to 65; ASA I-2; Institutional approval and informed consent. 

排除标准:

不能理解和配合神经功能评估和查体者; 有精神疾病的患者; 在研究开始前24小时服用过镇静药物者; 在研究开始前24小时服用过镇痛药物者; 药物和酒精滥用者; 孕期和围产期妇女; 复发肿瘤患者 

Exclusion criteria:

Unable to comprehend and cooperate with the neurologic examination; Impaired mental status; Taking sedative drugs in the past 24 hours ; Taking pain reliever in the past 24 hours; Drug and/or alcohol abuse; Preganant and/or lactation period woman; Recurrent brian tumor 

研究实施时间:

Study execute time:

From2013-01-15To  

干预措施:

Interventions:

组别:

异丙酚

样本量:

34

Group:

Propofol

Sample size:

干预措施:

给予异丙酚

干预措施代码:

Intervention:

Propofol Administer

Intervention code:

组别:

咪达唑仑

样本量:

34

Group:

Midazolam

Sample size:

干预措施:

给予咪达唑仑

干预措施代码:

Intervention:

Midazolam Administer

Intervention code:

组别:

芬太尼

样本量:

34

Group:

Fentanyl

Sample size:

干预措施:

给予芬太尼

干预措施代码:

Intervention:

Fentanyl Administer

Intervention code:

组别:

右旋美托咪啶

样本量:

34

Group:

Dexmedetomidine

Sample size:

干预措施:

给予右旋美托咪啶

干预措施代码:

Intervention:

Dexmedetomidine Administer

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:

三甲医院 

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:

NIS卒中评分

指标类型:

主要指标 

Outcome:

NIH Stoke Scale

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:

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):

由编程人员使用Excel软件生成随机数据表

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

Random number sequence was generated by Excel by IT.

盲法:

Blinding:

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:

即时公开/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):

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

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:

 2013-10-10
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