针灸辅助麻醉用于结肠镜诊疗术的效果研究

注册号:

Registration number:

AMCTR-IOR-19000281 

注册号获得时间:

Date of releasing the registration number:

2019/7/16 13:41:53 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针灸辅助麻醉用于结肠镜诊疗术的效果研究 

Public title:

Effect of acupuncture-assisted anesthesia on colonoscopy 

研究课题的正式科学名称:

针灸辅助麻醉用于结肠镜诊疗术的效果研究 

Scientific title:

Effect of acupuncture-assisted anesthesia on colonoscopy 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900024341 

申请注册联系人:

黄漫迎 

研究负责人:

余剑波 

Applicant:

Huang Manying 

Study leader:

Yu Jianbo 

申请注册联系人电话:

Applicant telephone:

+86 13397053486 

研究负责人电话:

Study leader's telephone:

+86 18698087176 

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:

1104803474@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jianboyu99@sina.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:

天津市和平区气象台路22号 

研究负责人通讯地址:

天津市和平区气象台路22号 

Applicant address:

22 Qixiangtai Road, Heping District, Tianjin, China 

Study leader's address:

6 Changjiang road, Nankai District,Tianjin, 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:

天津市南开医院 

Applicant's institution:

Tianjin Nankai 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:

2017-011P 

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:

天津市南开医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin Nankai Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-01-21 

研究实施负责(组长)单位:

天津市南开医院 

Primary sponsor:

Tianjin Nankai Hospital 

研究实施负责(组长)单位地址:

天津市天津市南开区长江道6号 

Primary sponsor's address:

6 Changjiang Road, Nankai District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市南开医院

具体地址:

天津市天津市南开区长江道6号

Institution
hospital:

Tianjin Nankai Hospital

Address:

6 Changjiang Road, Nankai District, Tianjin, China

经费或物资来源:

天津市131创新型人才团队项目 

Source(s) of funding:

Tianjin 131 innovative talents team project 

研究疾病:

结肠镜检查 

Target disease:

Colonoscopy 

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:

其它 

Study phase:

Other 

研究目的:

通过评价穴位刺激辅助麻醉在结肠镜检查过程中对麻醉药的用量,探讨针灸辅助麻醉在肠镜检查中应用的可能性。 

Objectives of Study:

To evaluate the possibility of acupuncture-assisted anesthesia in colonoscopy by evaluating the amount of anesthetic used in acupuncture stimulation assisted anesthesia during colonoscopy 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 年龄18~75岁,性别不限。 2. ASA I~II级 3. 签署知情同意书者。 

Inclusion criteria

1. Male and female aged 18 to 75 years old; 2. ASA I~II; 3. Signed informed consent. 

排除标准:

1. 患有严重的心、肺、脑等重要脏器疾病者; 2. 身体状况较为差无法耐受麻醉的患者; 3. 对所需使用的麻醉药物过敏者; 4. 有显著性呼吸系统疾患的病态肥胖者; 5. 了解中医针灸技术的患者; 6. 结肠切除手术史; 7. 肠道狭窄病史; 8. 精神疾病史 

Exclusion criteria:

;2. Patients with poor physical condition who cannot tolerate anesthesia; 3. Those who are allergic to the anesthetic drugs to be used; 4. morbidly obese people with significant respiratory diseases; 5. Understand the patients of traditional Chinese medicine acupuncture techniques; 6. With history of colectomy; 7. With history of intestinal stenosis; 8. With history of mental illness. 

研究实施时间:

Study execute time:

From2017-01-21To 2020-03-31 

干预措施:

Interventions:

组别:

A组

样本量:

100

Group:

group A

Sample size:

干预措施:

穴位刺激

干预措施代码:

Intervention:

Acupoint stimulation

Intervention code:

组别:

B组

样本量:

100

Group:

group B

Sample size:

干预措施:

假穴位刺激

干预措施代码:

Intervention:

False acupoint stimulation

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(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市南开医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Nankai Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

丙泊酚用量

指标类型:

主要指标 

Outcome:

丙泊酚用量

Type:

Primary indicator 

指标中文名:

行为疼痛评分

指标类型:

主要指标 

Outcome:

Behavioral pain score

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

其它 

说明

Fate of sample:

Others 

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 75 years

随机方法(请说明由何人用什么方法产生随机序列):

由计算机程序产生2组随机数字,每组各100个。随机分配方案的隐藏采用按顺序编码、密封、不透光的信封法。符合纳入标准的无痛结肠镜患者在签署知情同意书的前提下,按就诊时的顺序随机分配到两组中的一组。

性别:

男女均可

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

Two sets of random numbers are generated by a computer program, each set of 100. The hiding of the random allocation scheme uses an envelope method that is encoded, sealed, and opaque in sequence. Painless colonoscopy patients who met the inclusion criteria were randomly assigned to one of the two groups.

Gender:

Both

盲法:

未说明

Blinding:

Not stated

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:

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):

即时公开, Revman, http://www.medresman.org

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

Real time access, Revman, http://, medresman.org

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):

病例记录表 电子采集和管理系统

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

CRF EDC

创建人:

Creater Name:

 2019-07-15
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