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全麻期间应用脑电麻醉深度指数(IoC2)监测对瑞芬太尼应用的影响
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注册号:

Registration number:

ChiCTR-TRC-13004101 

最近更新日期:

Date of Last Refreshed on:

2016-06-26 

注册时间:

Date of Registration:

2013-11-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

全麻期间应用脑电麻醉深度指数(IoC2)监测对瑞芬太尼应用的影响 

Public title:

The application of EEG derived indices (IoC2) guided Remifentanil administration during general anesthesia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全麻期间应用脑电麻醉深度指数(IoC2)监测对瑞芬太尼应用的影响 

Scientific title:

The application of EEG derived indices (IoC2) guided Remifentanil administration during general anesthesia 

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:

吴桂生 

研究负责人:

吴桂生 

Applicant:

Guisheng Wu 

Study leader:

Guisheng Wu 

申请注册联系人电话:

Applicant telephone:

+86 18963510297 

研究负责人电话:

Study leader's telephone:

+86 18963510297 

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:

wuguisheng001@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wuguisheng001@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:

山东省聊城市东昌西路67号 

研究负责人通讯地址:

山东省聊城市东昌西路67号 

Applicant address:

67 West Dongchang Road, Liaocheng, Shandong, China 

Study leader's address:

67 West Dongchang Road, Liaocheng, Shandong, 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:

聊城市人民医院 

Applicant's institution:

Liaocheng People's Hospital 

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:

2013XJS-023 

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:

聊城市人民医院医学伦理委员会 

Name of the ethic committee:

Liaocheng People's Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-11-26 

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:

聊城市人民医院 

Primary sponsor:

Liaocheng People's Hospital 

研究实施负责(组长)单位地址:

山东省聊城市东昌西路67号 

Primary sponsor's address:

67 West Dongchang Road, Liaocheng, Shandong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-finacing 

研究疾病:

乳腺疾病 

Target disease:

Breast Diseases 

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:

全麻期间应用qNOX(IoC2)监测对瑞芬太尼应用的影响 

Objectives of Study:

The application of qNOX(IoC2) guided Remifentanil administration during general anesthesia 

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:

乳腺手术患者,18~60岁,ASAⅠ~Ⅱ级,BMI:18~30kg/m2 

Inclusion criteria

scheduled for elective breast surgery, aged 18-60yr, ASA status I-II, BMI:18~30kg/m2 

排除标准:

妊娠,对研究所用药物过敏,麻醉前基础血流动力学参数不正常(例如SBP>160mmHg或SBP<90mmHg,HR>90min-1或HR<45 min-1)。 

Exclusion criteria:

pregnancy,allergy to drugs used in this study, baseline hemodynamic index that would be considered as abnormal (such as SBP>160mmHg or SBP<90mmHg, HR>90min-1or HR<45 min-1). 

研究实施时间:

Study execute time:

From2014-01-20To 2014-06-02 

征募观察对象时间:

Recruiting time:

From2014-01-20To 2014-06-01 

干预措施:

Interventions:

组别:

qNOX(IoC2)组

样本量:

60

Group:

qNOX(IoC2) group

Sample size:

干预措施:

qNOX(IoC2) 指导瑞芬太尼的使用

干预措施代码:

Intervention:

qNOX(IoC2) guide the administration of remifentanil

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

麻醉医生根据经验调整瑞芬太尼用量

干预措施代码:

Intervention:

remifentanil was adapted by Anaesthesiologist corresponding to clinical experiences

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

聊城市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Liaocheng People's Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

麻醉药物的使用量

指标类型:

主要指标 

Outcome:

the consumption of anesthetics

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

工作人员预先准备按顺序编号的120个不透明的密封信封,每个信封中包含一个由计算机生成的随机数卡(奇数=ANI组)以确定分组。

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

clerks prepared 120 sequentially numbered opaque sealed envelopes, each containing a card with a num

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:

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-11-27
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