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Efficacy and safety of Remimazolam Tosilate for induction of general anesthesia in obese patients
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注册号:

Registration number:

ChiCTR2000038760 

最近更新日期:

Date of Last Refreshed on:

2020-09-30 

注册时间:

Date of Registration:

2020-09-30 

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应用于肥胖病人全身麻醉诱导的有效性和安全性研究 

Public title:

Efficacy and safety of Remimazolam Tosilate for induction of general anesthesia in obese patients 

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应用于肥胖病人全身麻醉诱导的有效性和安全性研究 

Scientific title:

Efficacy and safety of Remimazolam Tosilate for induction of general anesthesia in obese patients 

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:

王云 

研究负责人:

赵志斌 

Applicant:

Yun Wang 

Study leader:

Zhi-Bin Zhao 

申请注册联系人电话:

Applicant telephone:

15722875256 

研究负责人电话:

Study leader's telephone:

18961326661 

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:

2858093166@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

lygzhaozb@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:

江苏省连云港市江苏省连云港市海州区通灌北路182号  

研究负责人通讯地址:

江苏省连云港市江苏省连云港市海州区通灌北路182号  

Applicant address:

No. 182, Tongguan North Road, Haizhou District, Lianyungang City, Jiangsu Province  

Study leader's address:

No. 182, Tongguan North Road, Haizhou District, Lianyungang City, Jiangsu Province  

申请注册联系人邮政编码:

Applicant postcode:

222000 

研究负责人邮政编码:

Study leader's postcode:

222000 

申请人所在单位:

连云港市第一人民医院 

Applicant's institution:

Lianyungang First People's 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:

KY-20200622001-02 

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:

连云港市第一人民医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Lianyungang First People's Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-24 

伦理委员会联系人:

胡蓉 

Contact Name of the ethic committee:

Rong Hu 

伦理委员会联系地址:

江苏省连云港市海州区花果山街道振华东路6号 

Contact Address of the ethic committee:

6 Zhenhua East Road, Huaguoshan Street, Haizhou District, Lianyungang City, Jiangsu Province, China  

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:

连云港市第一人民医院 

Primary sponsor:

Lianyungang First People's Hospital  

研究实施负责(组长)单位地址:

江苏省连云港市海州区花果山街道振华东路6号 

Primary sponsor's address:

6 Zhenhua East Road, Huaguoshan Street, Haizhou District, Lianyungang City, Jiangsu Province, 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):

江苏

市(区县):

连云港

Country:

China

Province:

Jiang Su

City:

Lian Yun Gang

单位(医院):

连云港市第一人民医院

具体地址:

江苏省连云港市海州区花果山街道振华东路6号

Institution
hospital:

Lianyungang First People's Hospital

Address:

6 Zhenhua East Road, Huaguoshan Street, Haizhou District, Lianyungang City, Jiangsu Province, China

经费或物资来源:

科室经费 

Source(s) of funding:

Department funding 

研究疾病:

肥胖病人麻醉 

Target disease:

Obesity anesthesia 

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:

本研究拟探讨不同剂量的瑞马唑仑用于肥胖病人全身麻醉诱导期的可靠性和安全性,为后续临床上使用该药物提供一定的参考依据。 

Objectives of Study:

This study intends to explore the reliability and safety of different doses of Remimazolam Tosilate in the induction period of general anesthesia in obese patients, and to provide a certain reference for the subsequent clinical use of the drug. 

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≤65岁,性别不限; 2) 行择期手术(进行气管插管机械通气); 3) ASA评分为II-III级; 4) 30 kg/m2≤BMI<40kg/m2; 5) 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≤65 years old, no gender limit; 2) Perform elective surgery (for tracheal intubation and mechanical ventilation); 3) ASA score is II-III level; 4) 30 kg/m2≤BMI<40kg/m2; 5) Clearly understand and voluntarily participate in the research, and the informed consent form should be signed by him/herself. 

排除标准:

1) 急诊手术; 低血容量、 休克或者昏迷状态; 2) 计划行全身静脉麻醉以外还需合并其他麻醉方式,如吸入麻醉、硬膜外、蛛网膜下腔麻醉等; 3) 感染性心脏疾病如心肌炎或心内膜炎;败血症; 4) 未控制的高血压、糖尿病、心衰等; 5) 肝功能异常, AST 和/或 ALT≥2.5×ULN, TBIL≥1.5×ULN; 6) 肾功能异常, 尿素或尿素氮≥1.5×ULN,血肌酐大于正常值上限; 7) 患有精神系统疾病(精神分裂症、躁狂症、两极型异常、精神错乱 等)及长期服用精神类药物史及认知功能障碍者; 8) 妊娠或哺乳期的女性; 9) 对苯二氮卓类药物、阿片类药物、丙泊酚、肌松类等药物及其药物组分过敏或有禁忌者; 10) 研究者认为不宜参加此试验的其他情况。 

Exclusion criteria:

1) Emergency surgery; hypovolemia, shock or coma; 2) In addition to general intravenous anesthesia, other anesthesia methods, such as inhalation anesthesia, rigid extra-membrane and subarachnoid anesthesia, etc.; 3) Infectious heart diseases such as myocarditis or endocarditis; sepsis; 4) Uncontrolled hypertension, diabetes, heart failure, etc.; 5) Abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN; 6) Abnormal renal function, urea or urea nitrogen ≥1.5×ULN, and blood creatinine greater than the upper limit of normal; 7) Suffer from mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder Etc.) and those with long-term history of taking psychotropic drugs and cognitive impairment; 8) Women who are pregnant or breastfeeding; 9) Those who are allergic or contraindicated to benzodiazepines, opioids, propofol, muscle relaxants and other drugs and their drug components; 10) Other situations where the researcher thinks it is inappropriate to participate in this trial. 

研究实施时间:

Study execute time:

From2020-09-19To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-09-19To 2022-12-31 

干预措施:

Interventions:

组别:

2

样本量:

90

Group:

two

Sample size:

干预措施:

丙泊酚诱导

干预措施代码:

Intervention:

Drug intervention

Intervention code:

组别:

1

样本量:

90

Group:

one

Sample size:

干预措施:

瑞马唑仑诱导

干预措施代码:

Intervention:

Drug intervention

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):

连云港 

Country:

China 

Province:

Jiang Su 

City:

Lian Yun Gang 

单位(医院):

连云港市第一人民医院 

单位级别:

三甲 

Institution
hospital:

Lianyungang First People's Hospital  

Level of the institution:

Top three 

测量指标:

Outcomes:

指标中文名:

BIS值

指标类型:

主要指标 

Outcome:

BIS value

Type:

Primary indicator 

测量时间点:

麻醉诱导期

测量方法:

Measure time point of outcome:

Anesthesia induction period

Measure method:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

麻醉诱导期

测量方法:

Measure time point of outcome:

Anesthesia induction period

Measure method:

指标中文名:

麻醉镇静时间

指标类型:

次要指标 

Outcome:

Sedation 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:

麻醉诱导时间

指标类型:

次要指标 

Outcome:

Anesthesia induction time

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):

由参加研究的一名麻醉医生进行随机化分组,随机方案通过查阅随机对照表

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

Randomization is carried out by an anesthesiologist participating in the study, and the randomization plan is generated by consulting a randomized comparison table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

时间:2023-6-01 方式:连云港市第一人民医院集成办公 http://oa.lygyy.com.cn

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

Time: 2023-6-01 Mode: Lianyungang First People's Hospital Integrated Office http://oa.lygyy.com.cn

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:

采用病例记录表

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

Use case record form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-09-30
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