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Low-dose esketamine as an adjuvant to propofol sedation for same-visit bidirectional endoscopy: a prospective, multicenter, randomized, controlled trial
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注册号:

Registration number:

ChiCTR2200055938 

最近更新日期:

Date of Last Refreshed on:

2022-01-26 

注册时间:

Date of Registration:

2022-01-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

小剂量艾司氯胺酮联合丙泊酚在无痛胃肠镜检查中的应用:一项前瞻性、多中心、随机、对照试验 

Public title:

Low-dose esketamine as an adjuvant to propofol sedation for same-visit bidirectional endoscopy: a prospective, multicenter, randomized, controlled trial 

注册题目简写:

艾司-丙泊酚胃肠镜试验 

English Acronym:

The EPSE trial 

研究课题的正式科学名称:

小剂量艾司氯胺酮联合丙泊酚在无痛胃肠镜检查中的应用:一项前瞻性、多中心、随机、对照试验 

Scientific title:

Low-dose esketamine as an adjuvant to propofol sedation for same-visit bidirectional endoscopy: a prospective, multicenter, randomized, controlled trial 

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:

彭科 

研究负责人:

嵇富海 

Applicant:

Ke Peng 

Study leader:

Fu-hai Ji 

申请注册联系人电话:

Applicant telephone:

+86-15962155989 

研究负责人电话:

Study leader's telephone:

+86-13656207331 

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:

pengke0422@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jifuhai@hotmail.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:

中国江苏省苏州市十梓街188号 

研究负责人通讯地址:

中国江苏省苏州市十梓街188号 

Applicant address:

188 Shizi Street, Suzhou, Jiangsu, China  

Study leader's address:

188 Shizi Street, Suzhou, Jiangsu, China  

申请注册联系人邮政编码:

Applicant postcode:

215006 

研究负责人邮政编码:

Study leader's postcode:

215006 

申请人所在单位:

苏州大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Soochow 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:

(2021) 伦审批第233号 

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:

苏州大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of the First Affiliated Hospital of Soochow University  

伦理委员会批准日期:

Date of approved by ethic committee:

2021-10-12 

伦理委员会联系人:

吴霜杰 

Contact Name of the ethic committee:

Shuangjie Wu 

伦理委员会联系地址:

中国江苏省苏州市平海路899号 

Contact Address of the ethic committee:

899 Pinghai Road, Suzhou, Jiangsu, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

0512-67780655 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sdfyec@163.com 

研究实施负责(组长)单位:

苏州大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

江苏省苏州市十梓街188号 

Primary sponsor's address:

No.188 Shizi Street 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州大学附属第一医院

具体地址:

江苏省苏州市十梓街188号

Institution
hospital:

First Affiliated Hospital of Soochow University

Address:

No.188 Shizi Street

经费或物资来源:

临床试验科技发展计划、江苏省333高层次人才计划、江苏省六大人才高峰项目 

Source(s) of funding:

Science and Technology Development Plan Clinical Trial Project, 333 High-level Talent Training Project in Jiangsu Province, Six Talent Peaks Project in Jiangsu Province 

研究疾病:

消化内镜检查的镇静 

Target disease:

Sedation for gastrointestinal endoscopy 

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:

对拟在麻醉镇静下行胃镜加肠镜检查的成年患者中,评估在常规基于丙泊酚的基础上加用小剂量艾司氯胺酮对主要并发症(定义为发生氧饱和度下降或低血压的复合终点)的影响。 

Objectives of Study:

To evaluate the effects of low-dose esketamine as an adjuvant to propofol-based sedation on major complications (a composite outcome of desaturation and hypotension) in adult patients undergoing same-visit bidirectional endoscopy. 

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:

年龄18-70周岁,性别不限;美国麻醉医师分级(ASA)I或Ⅱ级;体重指数18-30kg/m2,需行无痛胃镜加肠镜检查患者 

Inclusion criteria

Patients aged 18 to 70 years, ASA physical status I to II, BMI 18-30 kg/m2, scheduled for same-visit bidirectional endoscopy under sedation. 

排除标准:

严重的心血管或肺部疾病、肝肾功能障碍、神经认知或精神系统疾病、癫痫、对研究药物过敏、药物或酒精滥用、或拒绝参与。 

Exclusion criteria:

Severe cardiovascular or pulmonary diseases, renal or liver dysfunction, neurocognitive or psychiatric disorders, epilepsy, hypersensitivity to study medications, drug or alcohol misuse, or refusal to participate.  

研究实施时间:

Study execute time:

From2022-02-08To 2022-11-30 

征募观察对象时间:

Recruiting time:

From2022-02-08To 2022-11-30 

干预措施:

Interventions:

组别:

对照组

样本量:

330

Group:

normal saline group

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

normal saline

Intervention code:

组别:

干预组

样本量:

330

Group:

esketamine group

Sample size:

干预措施:

艾司氯胺酮

干预措施代码:

Intervention:

esketamine 0.15mg/kg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Soochow University  

Level of the institution:

Class III Grade A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

太仓 

Country:

China 

Province:

Jiangsu 

City:

Taicang 

单位(医院):

太仓市第一人民医院 

单位级别:

三级乙等 

Institution
hospital:

Taicang First People’s Hospital  

Level of the institution:

Class III Grade B 

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州高新区人民医院 

单位级别:

Class II Grade A 

Institution
hospital:

The People's Hospital of SND  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

氧饱和度下降

指标类型:

次要指标 

Outcome:

desaturation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

intra-procedure

Measure method:

SpO2<90%

指标中文名:

低血压

指标类型:

次要指标 

Outcome:

hypotension

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

intra-procedure

Measure method:

SBP<80mmHg or decrease>30% from baseline

指标中文名:

丙泊酚的总剂量

指标类型:

次要指标 

Outcome:

total dose of propofol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

intra-procedure

Measure method:

指标中文名:

疼痛评分

指标类型:

次要指标 

Outcome:

pain scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

at emergence and 15 min later

Measure method:

NRS (0-10)

指标中文名:

疲劳评分

指标类型:

次要指标 

Outcome:

fatigue scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

at emergence and 15 min later

Measure method:

NRS (0-10)

指标中文名:

头晕头痛

指标类型:

次要指标 

Outcome:

dizziness or headache

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

in the recovery room

Measure method:

指标中文名:

幻觉噩梦

指标类型:

次要指标 

Outcome:

hallucination or nightmare

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

in the recovery room

Measure method:

指标中文名:

恶心呕吐

指标类型:

次要指标 

Outcome:

nausea or vomiting

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

in the recovery room

Measure method:

指标中文名:

内镜医师满意度

指标类型:

次要指标 

Outcome:

endoscopist satisfaction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

post-procedure

Measure method:

指标中文名:

患者满意度

指标类型:

次要指标 

Outcome:

patient satisfaction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

in the recovery room

Measure method:

指标中文名:

氧饱和度下降或低血压的复合终点

指标类型:

主要指标 

Outcome:

a composite outcome of desaturation and hypotension

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

intra-procedure

Measure method:

desaturation (SpO2<90%), hypotension (SBP<80mmHg or decrease>30% from baseline)

采集人体标本:

Collecting sample(s)
from participants:

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 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):

由一名独立研究人员使用在线工具进行区组随机化(可变区组大小为2和4),按各中心分层,按1:1的比例将招募的参与者分配到丙泊酚组或丙泊酚联合艾司氯胺酮组中。

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

An independent biostatistician generates the randomization list using an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists), with an allocation ratio of 1:1, permuted blocks of 2 and 4, and stratification by study center.

盲法:

每个中心由独立的研究护士配置药物至相同的注射器之中。艾司氯胺酮和生理盐水安慰剂都是无色透明液体。所有患者、研究人员、结局观察者,都对分组不知情。

Blinding:

Both esketamine and normal saline placebo are clear and colorless fluids. To achieve blinding to group assignment among patients, care teams, and outcome evaluators, an independent research nurse in each center will distribute the study medications in identical syringes labelled with study numbers only.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

网络平台数据库

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

Network Platform Database

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:

标准的病例记录表格和电子管理系统

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

A standard data collection and management system including a Case Record Form (CRF) and an Electronic Data Capture (EDC)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-26
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