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注射用甲苯磺酸瑞马唑仑用于胃镜诊疗镇静的多中心、随机、单盲临床试验
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注册号:

Registration number:

ChiCTR2000038694 

最近更新日期:

Date of Last Refreshed on:

2020-09-28 

注册时间:

Date of Registration:

2020-09-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

注射用甲苯磺酸瑞马唑仑用于胃镜诊疗镇静的多中心、随机、单盲临床试验 

Public title:

Clinical study of remimazolam tosilate for injection for gastroscopic sedation: a multicenter, randomized, single-blind clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

注射用甲苯磺酸瑞马唑仑用于胃镜诊疗镇静的多中心、随机、单盲临床试验 

Scientific title:

Clinical study of remimazolam tosilate for injection for gastroscopic sedation: a multicenter, randomized, single-blind clinical 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:

王春艳 

研究负责人:

于泳浩 

Applicant:

Chunyan Wang 

Study leader:

Yonghao Yu 

申请注册联系人电话:

Applicant telephone:

8613512206486 

研究负责人电话:

Study leader's telephone:

8613920590099 

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:

513245098@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yuyonghao@126.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:

天津市和平区鞍山道152号 

研究负责人通讯地址:

天津市和平区鞍山道152号 

Applicant address:

152 Anshan road, Heping district, Tianjin 

Study leader's address:

152 Anshan road, Heping 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:

天津医科大学总医院麻醉科 

Applicant's institution:

Department of Anesthesiology, General Hospital of Tianjin Medical 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:

IRB2020-YX-040-01 

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:

天津医科大学总医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tianjin Medical University General Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-02 

伦理委员会联系人:

金冬来 

Contact Name of the ethic committee:

Donglai Jin 

伦理委员会联系地址:

天津市和平区鞍山道152号 

Contact Address of the ethic committee:

152 Anshan road, Heping district, Tianjin 

伦理委员会联系人电话:

Contact phone of the ethic committee:

022-60361044 

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:

天津医科大学总医院 

Primary sponsor:

Tianjin Medical University General Hospital  

研究实施负责(组长)单位地址:

天津市和平区鞍山道152号 

Primary sponsor's address:

152 Anshan road, Heping 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):

天津医科大学总医院

具体地址:

天津市和平区鞍山道152号

Institution
hospital:

Tianjin Medical University General Hospital

Address:

152 Anshan road, Heping district, Tianjin

经费或物资来源:

中国健康促进基金会 

Source(s) of funding:

中国健康促进基金会 

研究疾病:

胃镜检查 

Target disease:

Gastroscopy 

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:

上市后药物 

Study phase:

研究目的:

1.主要目标:探讨瑞马唑仑用于胃镜诊疗镇静成功率及对睡眠状况的影响 1)体动评分 2)胃镜医师对麻醉效果满意度 3)镇静成功率 4)对睡眠状况的影响:采用SRSS进行评估 2.次要目标: 1)镇静诱导时间; 2)镇静苏醒时间; 3)镇静低血压发生率;需治疗的镇静低血压发生率; 4)镇静过程中呼吸抑制发生率; 3.其他目标: 探讨瑞马唑仑用于胃镜诊疗镇静的最佳使用方案 

Objectives of Study:

1. Main objective: to explore the sedation success rate of remazolam in gastroscopy and its effect on sleep status. 1) body movement score. 2) the gastroscope physician is satisfied with the anesthetic effect. 3) sedation success rate. 4) effect on sleep status: assessed by SRSS. 2 Secondary goal: 1) sedation induction time. 2) sedation and awakening time. 3) incidence of sedative hypotension; incidence of sedative hypotension requiring treatment. 4) incidence of respiratory depression during sedation. 3. Other objectives: to explore the best use of ramazolam for gastroscopy sedation. 

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:

1) 18≤年龄≤70岁,性别不限; 2) 接受常规胃镜诊疗的患者; 3) ASA评分为I级或 II 级; 4) 18 kg/m2<BMI<30kg/ m2; 5) 预计胃镜操作时间不超过30min; 6) 无睡眠障碍障碍; 7) 清楚了解、自愿参加该项研究,并由其本人签署知情同意书。 

Inclusion criteria

1) 18 ≤ age ≤ 70 years old, regardless of sex. 2) patients who receive routine gastroscopy. 3) ASA score is I or II. 4) 18 kg/m2 < BMI < 30kg/ m2. 5) the operation time of gastroscope is expected to be no longer than that of 30min. 6) No sleep disorder. 7) clearly understand and voluntarily participate in the study, and the informed consent form shall be signed by him. 

排除标准:

具有以下任何一项的患者不能入组本研究: 1)需要进行操作复杂的内镜诊疗技术(如胰胆管造影术、超声内镜、内镜 下黏膜 切除术、内镜黏膜下层剥离术、经口内镜下肌离断术等); 2)拟行气管插管的患者; 3)被判定为呼吸道管理困难(改良马氏评分为IV 级)患者; 4)贫血或者血小板减少,Hb<90g/L,PLT<80×109 /L 5)肝功能异常,AST 和/或ALT≥2.5×ULN,TBIL≥1.5×ULN; 6)肾功能异常,血肌酐大于正常值上限; 7)筛选期开始前2 年内有吸毒史和/或酗酒史,酗酒即每日平均饮酒超过2单位酒 (1 单位=360 mL 啤酒或45 mL 酒精量为40%的白酒或150 mL 葡萄酒); 8)经降压药物治疗血压未获满意控制的高血压患者(筛选期坐位收缩压≥160 mmHg,和/或筛选期舒张压≥100 mmHg); 9)筛选期坐位收缩压≤90 mmHg; 10)妊娠或哺乳期的女性; 11)对苯二氮卓类药物、阿片类药物、丙泊酚、利多卡因及其药物组分过敏或有禁忌; 12)近3个月内作为受试者参加过其他药物临床试验; 13)研究者认为不宜参加此试验患者; 

Exclusion criteria:

Patients with any of the following items cannot be enrolled in this study: 1) complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, transoral endoscopic myotomy, etc.). 2) patients who are going to undergo endotracheal intubation. 3) patients with respiratory tract management difficulties (modified Mahalanobis score as IV). 4) anemia or thrombocytopenia, Hb < 90g / L < 80 × 109 / L. 5) abnormal liver function, AST and / or ALT ≥ 2.5 × ULN,TBIL ≥ 1.5 × ULN. 6) the renal function is abnormal and the serum creatinine is higher than the upper limit of the normal value. 7) there is a history of drug use and / or alcohol abuse in the 2 years before the start of the screening period, that is, drinking more than 2 units of alcohol per day on average. (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine). 8) hypertensive patients whose blood pressure was not satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure ≥ 160mmHg, and / or screening diastolic blood pressure ≥ 100mmHg). 9) the systolic blood pressure of sitting position during the screening period is less than 90 mmHg. 10) pregnant or lactating women. 11) allergic or taboo to benzodiazepines, opioids, propofol, lidocaine and their drug components. 12) participated in clinical trials of other drugs as subjects in the past 3 months. 13) the researchers do not think it is appropriate for patients to participate in this trial. 

研究实施时间:

Study execute time:

From2020-09-30To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2020-09-30To 2020-09-01 

干预措施:

Interventions:

组别:

3

样本量:

80

Group:

3

Sample size:

干预措施:

瑞马唑仑

干预措施代码:

Intervention:

Intervention code:

组别:

2

样本量:

80

Group:

2

Sample size:

干预措施:

丙泊酚

干预措施代码:

Intervention:

propofol

Intervention code:

组别:

1

样本量:

80

Group:

1

Sample size:

干预措施:

瑞马唑仑+丙泊酚

干预措施代码:

Intervention:

remimazolam + propofol

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):

天津医科大学总医院 

单位级别:

三甲 

Institution
hospital:

Tianjin Medical University General Hospital  

Level of the institution:

Third-class hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第四中心医院 

单位级别:

三甲 

Institution
hospital:

Tianjin fourth Central Hospital  

Level of the institution:

Third-class hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学第二医院 

单位级别:

三甲 

Institution
hospital:

The second Hospital of Tianjin Medical University  

Level of the institution:

Third-class hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市静海区医院 

单位级别:

三甲 

Institution
hospital:

Jinghai Hospital  

Level of the institution:

Third-class hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

北京大学滨海医院 

单位级别:

三级 

Institution
hospital:

Peking University Binhai Hospital  

Level of the institution:

Third-class hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市泰达医院 

单位级别:

三级 

Institution
hospital:

TEDA Hospital  

Level of the institution:

Third-class hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市宝坻区人民医院 

单位级别:

三甲 

Institution
hospital:

Tianjin Baodi hospital  

Level of the institution:

Third-class hospital 

测量指标:

Outcomes:

指标中文名:

镇静成功率

指标类型:

主要指标 

Outcome:

Sedation success rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对睡眠状况的影响

指标类型:

主要指标 

Outcome:

Effect on sleep status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃镜医师对麻醉效果满意度

指标类型:

主要指标 

Outcome:

Gastroscopy physician's satisfaction with the effect of anesthesia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体动评分

指标类型:

主要指标 

Outcome:

Body movement score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇静诱导时间

指标类型:

次要指标 

Outcome:

Sedation induction time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇静苏醒时间

指标类型:

次要指标 

Outcome:

Sedation and awakening time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇静低血压发生率

指标类型:

次要指标 

Outcome:

Incidence of hypotension

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇静过程中呼吸抑制发生率

指标类型:

次要指标 

Outcome:

Incidence of respiratory depression during sedation

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

研究者团队中的负责随机分组的人员按照随机数字表法进行随机

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

The people in the team of researchers who are in charge of random grouping are randomly divided into groups according to the random number table method.

盲法:

Blinding:

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):

2023年,邮箱513245098@qq.com

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

Date:2023; 513245098@qq.com

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-09-28
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