今天是:2019-09-17 星期二

小剂量瑞芬太尼输注对全麻苏醒期躁动及术后认知功能的影响
下载XML文档

注册号:

Registration number:

ChiCTR1900024254 

最近更新日期:

Date of Last Refreshed on:

2019-07-03 

注册时间:

Date of Registration:

2019-07-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

小剂量瑞芬太尼输注对全麻苏醒期躁动及术后认知功能的影响 

Public title:

The effect of low-dose remifentanil infusion on emergence agitation and POCD 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

小剂量瑞芬太尼输注对全麻苏醒期躁动及术后认知功能的影响 

Scientific title:

The effect of low-dose remifentanil infusion on emergence agitation and POCD 

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:

姚永兴 

研究负责人:

姚永兴 

Applicant:

Yongxing Yao 

Study leader:

Yongxing Yao 

申请注册联系人电话:

Applicant telephone:

+86 13656668373 

研究负责人电话:

Study leader's telephone:

+86 13656668373 

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:

yaoyongxing@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

yaoyongxing@zju.edu.cn 

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:

杭州市庆春路79号 

研究负责人通讯地址:

杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou 

Study leader's address:

79 Qingchun Road, Hangzhou 

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:

浙江大学医学院附属第一医院 

Applicant's institution:

First Affiliated Hospital, Zhejiang University School of Medicine 

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:

2019-86 

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:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-13 

伦理委员会联系人:

殷琳 

Contact Name of the ethic committee:

Lin Yin 

伦理委员会联系地址:

杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou 

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:

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:

杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

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:

庆春路79号

Institution
hospital:

First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road

经费或物资来源:

国家自然科学基金委(81471127) 

Source(s) of funding:

National Natural Science Foundation of China (81471127) 

研究疾病:

术后躁动及认知功能障碍 

Target disease:

EA and POCD 

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:

观察术后持续小剂量瑞芬太尼输注对全麻苏醒期躁动及认知功能障碍发生率的影响。评价瑞芬太尼对改善患者全麻苏醒质量及血流动力学稳定的作用,及缩短PACU停留方面的作用。 

Objectives of Study:

To observe the effect of continuous low-dose remifentanil infusion on the incidence of agitation and cognitive dysfunction during general anesthesia recovery. To evaluate the effect of remifentanil on improving the quality and hemodynamic stability of patients after general anesthesia, and reduce the duration of PACU stay. 

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:

全身麻醉后苏星期躁动患者200例,年龄18~90 岁,体重40~100 kg,性别不限,ASA 1-3级。 

Inclusion criteria

200 patients aged 18 to 90 years, weighing 40 to 100 kg, gender is not limited, ASA 1-3 grade, with emergence aditation.  

排除标准:

既往有严重心肺肝肾疾病、颅内压升高史、阿片类药物长期使用史、妊娠期、对试验用药过敏史、近期上呼吸道感染史、慢性咳嗽病史。 

Exclusion criteria:

Patients with previous severe heart, lung, liver or kidney disease, history of elevated intracranial pressure, long-term use of opioids, pregnancy, history of allergies to test medication, recent history of upper respiratory tract infection, history of chronic cough. 

研究实施时间:

Study execute time:

From2019-07-15To 2022-07-14 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

瑞芬太尼剂量为0.1-0.2μg /( kg.min)

干预措施代码:

Intervention:

Remifentanil 0.1-0.2μg /( kg.min)

Intervention code:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

Normal saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

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:

三级甲等 

Institution
hospital:

First Affiliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

术后躁动及认知功能障碍的发生率

指标类型:

主要指标 

Outcome:

incidence of emergence agitation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能评分

指标类型:

次要指标 

Outcome:

cognitive score

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:

血液

组织:

Sample Name:

Blood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 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):

瑞芬太尼组和空白组根据SPSS产生的随机数据表来进行分组。

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

The remifentanil group and the control group were grouped according to a random data table generated by the SPSS.

盲法:

双盲

Blinding:

Double blind

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):

共享日期为本研究论文发表后;共享方式为上传至数据库Revman, http://www.medresman.org

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

We will share the IPD after the research paper is published by uploading to database Revman, http://www.medresman.org

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:

采用SPSS保存和搜集数据库.

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

We manage the data with SPSS.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-03
返回列表