经皮穴位电刺激对依托咪酯麻醉效能的影响

注册号:

Registration number:

AMCTR-IPR-20000342 

注册号获得时间:

Date of releasing the registration number:

2020/7/30 9:11:27 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

经皮穴位电刺激对依托咪酯麻醉效能的影响 

Public title:

The effect of transcutaneous acupoint electrical stimulation on the anesthesia efficacy of etomidate 

研究课题的正式科学名称:

经皮穴位电刺激对依托咪酯麻醉效能的影响 

Scientific title:

The effect of transcutaneous acupoint electrical stimulation on the anesthesia efficacy of etomidate 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

谭彬彬 

研究负责人:

陈君 

Applicant:

Tan Binbin 

Study leader:

Chen Jun 

申请注册联系人电话:

Applicant telephone:

13820187525 

研究负责人电话:

Study leader's telephone:

13820187525 

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:

bibli0417@163.com 

研究负责人电子邮件:

Study leader's E-mail:

bibli0417@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:

天津市津南区吉兆路6号 

研究负责人通讯地址:

天津市津南区吉兆路6号 

Applicant address:

No. 6, Jizhao Road, Jinnan District, Tianjin 

Study leader's address:

No. 6, Jizhao Road, Jinnan District, Tianjin 

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:

天津市环湖医院 

Applicant's institution:

Tianjin Huanhu 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:

2020-16 

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:

天津市环湖医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin Huanhu Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-19 

研究实施负责(组长)单位:

天津市环湖医院 

Primary sponsor:

Tianjin Huanhu Hospital 

研究实施负责(组长)单位地址:

天津市津南区吉兆路6号 

Primary sponsor's address:

No. 6, Jizhao Road, Jinnan District, Tianjin 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市环湖医院

具体地址:

天津市津南区吉兆路6号

Institution
hospital:

Tianjin Huanhu Hospital

Address:

No. 6, Jizhao Road, Jinnan District, Tianjin

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

颈内动脉狭窄 

Target disease:

Carotid artery stenosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

经皮穴位电刺激在围术期具有广泛的作用,其既能减少全身麻醉术中麻醉药用量,又可以减轻围术期全身麻醉并发症,可以安全用于各类手术的麻醉。依托咪酯是一种对循环系统没有明显的抑制作用的静脉麻醉药,可以在降低颅内压的同时维持脑灌注,具有明显的脑保护作用,特别适合用于神经外科手术麻醉,因此本研究拟以接受颈内动脉内膜剥脱术的患者为研究对象,探讨内关、合谷、足三里穴经皮穴位电刺激对依托咪酯在全凭静脉全麻中麻醉效能的影响,为临床工作提供参考。 

Objectives of Study:

Transcutaneous acupoint electrical stimulation has a wide range of effects during the perioperative period. It can not only reduce the amount of anesthetic used in general anesthesia, but also alleviate the complications of general anesthesia during the perioperative period. It can be safely used for various types of anesthesia. Etomidate is an intravenous anesthetic that has no significant inhibitory effect on the circulatory system. It can maintain cerebral perfusion while reducing intracranial pressure. It has obvious brain protection and is particularly suitable for neurosurgical anesthesia. Therefore, this study It is planned to take patients undergoing endarterectomy of internal carotid artery as the research object to explore the effect of percutaneous electrical stimulation on acupoints of Neiguan, Hegu and Zusanli on the anesthetic efficacy of etomidate in total intravenous anesthesia to provide clinical work reference. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

拟在全麻下行颈内动脉内膜剥脱手术的患者,年龄18-65岁, ASA分级Ⅰ或Ⅱ级,体重指数18~30 kg/m2 

Inclusion criteria

Patients underwent general carotid endarterectomy for general anesthesia, aged 18-65 years, ASA grade I or II, body mass index 18~30 kg/m2 

排除标准:

术前应用影响实验结果的镇痛催眠药物,有中枢神经系统疾病病史,心、肺、肝、肾、肾上腺功能有明显异常,有酒精药物滥用史。 

Exclusion criteria:

Using preoperative analgesic and hypnotic drugs that affect the experimental results, have a history of central nervous system diseases, heart, lung, liver, kidney, and adrenal gland functions are obviously abnormal, and there is a history of alcohol abuse. 

研究实施时间:

Study execute time:

From2021-08-01To 2021-03-31 

干预措施:

Interventions:

组别:

TEAS组

样本量:

30

Group:

TEAS Group

Sample size:

干预措施:

经皮穴位电刺激

干预措施代码:

Intervention:

Transcutaneous acupoint electrical stimulation

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津市 

市(区县):

 

Country:

CHINA 

Province:

Tianjin 

City:

 

单位(医院):

天津市环湖医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Huanhu Hospital  

Level of the institution:

Grade-A Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

依托咪酯使患者意识消失时的EC50

指标类型:

主要指标 

Outcome:

EC50 when etomidate causes the patient to lose consciousness

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

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

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

设计者通过随机数表法产生

性别:

男女均可

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

The designer generates it through the random number table method

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

ResMan http://d.medsci.cn

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

ResMan http://d.medsci.cn

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

数据包括原始记录和病例记录表,采用ResMan数据库

The repository and management of the data(Please specify what repository will be used for management of the metadata):

The data includes original records and case records, using ResMan database

创建人:

Creater Name:

 2020-06-29
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