今天是:2019-11-15 星期五

全麻过程中的眼动对声音序列的追踪情况的研究
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注册号:

Registration number:

ChiCTR1900026590 

最近更新日期:

Date of Last Refreshed on:

2019-10-15 

注册时间:

Date of Registration:

2019-10-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

全麻过程中的眼动对声音序列的追踪情况的研究 

Public title:

Study for Eye Movements Tracks Auditory Sequence During General Anesthesia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全麻过程中的眼动对声音序列的追踪情况的研究 

Scientific title:

Study for Eye Movements Tracks Auditory Sequence During General Anesthesia 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(31771202,81471171);浙江省医疗健康科技项目(2017KY352);人文社会科学教育部项目(No.17YJA190005)  

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:

张德林 

研究负责人:

张德林 

Applicant:

Zhang Delin 

Study leader:

Zhang Delin 

申请注册联系人电话:

Applicant telephone:

+86 13588495238 

研究负责人电话:

Study leader's telephone:

+86 13588495238 

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:

50887532@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

50887532@qq.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China  

申请注册联系人邮政编码:

Applicant postcode:

310000 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

the First Affiliated Hospital, College of Medicine, Zhejiang 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:

20191362 

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:

浙江大学医学院附属第一医院 

Name of the ethic committee:

the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-11 

伦理委员会联系人:

殷琳 

Contact Name of the ethic committee:

Yin Lin 

伦理委员会联系地址:

浙江大学医学院附属第一医院庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13515818875 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

First Affiliated Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙大玉泉校区 

Primary sponsor's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江大学医学院附属第一医院庆春路79号

Institution
hospital:

the First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China

经费或物资来源:

经费来源为国家自然科学基金(31771202,81471171);浙江省医疗健康科技项目(2017KY352);人文社会科学教育部项目(No.17YJA190005)  

Source(s) of funding:

The National Natural Science Foundation of China (31771202, 81471171); Medical and Health Science and Technology Project of Zhejiang Province (2017KY352) and MOE (17YJA190005)  

研究疾病:

麻醉深度 

Target disease:

Depth of general anesthesia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

观察全麻过程中眼动对声音序列追踪能力的变化。探究其背后原理,探讨声音序列驱动下的眼动能否成为一个新的判断全麻手术中的意识状况的指标。 

Objectives of Study:

Observe the changes in the ability of eye movements to track auditory sequences during anesthesia. Exploring the principles behind it and exploring whether eye movements driven by auditory sequences can be a new indicator of the state of consciousness in 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:

连续入组 

Study design:

Sequential 

纳入标准:

(1)全麻手术、同时需要麻醉监测的病人; (2)年龄≥18岁 (3)ASA I到II级  

Inclusion criteria

(1)Patients undergoing general anesthesia and requiring anesthesia monitoring; (2) aged >=18 years; (3) ASA I-II. 

排除标准:

(1)麻醉用药禁忌; (2)长期服用镇静催眠或抗精神病药物; (3)精神异常,有癫痫病史; (4)听力有障碍; (5)患者未签署知情同意书;  

Exclusion criteria:

(1)anaesthesia contraindication; (2)long-term use of sedative hypnotic or antipsychotic drugs; (3)mental abnormalities, a history of epilepsy; (4)Hearing disorder; (5)unsigned the informed consent form. 

研究实施时间:

Study execute time:

From2019-03-10To 2019-12-20 

干预措施:

Interventions:

组别:

Case series

样本量:

40

Group:

Case series

Sample size:

干预措施:

全身麻醉深度

干预措施代码:

Intervention:

Depth of general anesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

七氟醚药物浓度

指标类型:

主要指标 

Outcome:

Sevoflurane concentrations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BIS值

指标类型:

次要指标 

Outcome:

BIS Value

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:

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 70 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):

连续病例收集,无随机对照

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

collection of series cases, no randomization procedure was conducted.

盲法:

N/A

Blinding:

N/A

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):

公布在ResMan平台

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

publicated on ResMan

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:

CRF表采集数据,数据电子存档管理

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

collect data by CRF, and manage data via computer.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-15
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