今天是:2020-09-23 星期三

不同剂量舒更葡糖钠在腹腔镜减重代谢手术中拮抗罗库溴铵所致深肌松的安全性和有效性的比较:一项前瞻性、随机、平行对照研究
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注册号:

Registration number:

ChiCTR1900028652 

最近更新日期:

Date of Last Refreshed on:

2019-12-29 

注册时间:

Date of Registration:

2019-12-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同剂量舒更葡糖钠在腹腔镜减重代谢手术中拮抗罗库溴铵所致深肌松的安全性和有效性的比较:一项前瞻性、随机、平行对照研究 

Public title:

A prospective, randomized, controlled trial for the safety and efficacy of different dosage sugammadex for reversal of rocuronium-induced deep neuromuscular blockade in morbidly obese patients undergoing Laparoscopic Bariatric Surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同剂量舒更葡糖钠在腹腔镜减重代谢手术中拮抗罗库溴铵所致深肌松的安全性和有效性的比较:一项前瞻性、随机、平行对照研究 

Scientific title:

A prospective, randomized, controlled trial for the safety and efficacy of different dosage sugammadex for reversal of rocuronium-induced deep neuromuscular blockade in morbidly obese patients undergoing Laparoscopic Bariatric Surgery 

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:

李德明 

研究负责人:

印春铭 

Applicant:

Deming Li 

Study leader:

Chunming Yin 

申请注册联系人电话:

Applicant telephone:

+86 18900912988 

研究负责人电话:

Study leader's telephone:

+86 18900912998 

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:

li_deming@163.com 

研究负责人电子邮件:

Study leader's E-mail:

cmu4h_ycm@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:

辽宁省沈阳市皇姑区崇山东路4号 

研究负责人通讯地址:

辽宁省沈阳市皇姑区崇山东路4号 

Applicant address:

4 East Chongshan Road, Huanggu District, Shenyang, Liaoning, China 

Study leader's address:

4 East Chongshan Road, Huanggu District, Shenyang, Liaoning, 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:

中国医科大学附属第四医院麻醉科 

Applicant's institution:

Department of Anesthesiology, The Fourth Affiliated Hospital of China 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:

ECDCTS-2019-HS-002 

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:

中国医科大学附属第四医院药物临床试验伦理委员会 

Name of the ethic committee:

The Ethics Committee for Drug Clinical Trials & Study, the Fourth Affiliated Hospital, China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-28 

伦理委员会联系人:

赵海鹰 

Contact Name of the ethic committee:

Haiying Zhao 

伦理委员会联系地址:

辽宁省沈阳市皇姑区崇山东路4号 

Contact Address of the ethic committee:

4 East Chongshan Road, Huanggu District, Shenyang, Liaoning, 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:

中国医科大学附属第四医院 

Primary sponsor:

The Fourth Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

辽宁省沈阳市皇姑区崇山东路4号 

Primary sponsor's address:

4 East Chongshan Road, Huanggu District, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属第四医院

具体地址:

沈阳市皇姑区崇山东路4号

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University

Address:

4 East Chongshan Road, Huanggu District, Shenyang

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised funds 

研究疾病:

神经肌肉阻滞 

Target disease:

Neuromuscular Blockade 

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:

探讨舒更葡糖钠按实际体重和校正体重给药,在病态肥胖患者腹腔镜减重代谢手术中应用的安全性和有效性 

Objectives of Study:

To investigate the safety and efficacy of different dosage sugammadex according to Total versus corrected body weight in morbidly obese patients undergoing Laparoscopic Bariatric Surgery 

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、年龄≥18岁,≤60岁; 2、ASA分级1-3级; 3、BMI≥40kg/m2 的行腹腔镜减重代谢手术患者; 4、同意本研究并签署知情同意书。 

Inclusion criteria

1. Aged 18 to 60 years; 2. American Society of Anesthesiologists (ASA) physical status 1-3; 3. Patients with BMI>=40kg/m2 undergoing Laparoscopic Bariatric Surgery; 4. Agree to this study and sign informed consent. 

排除标准:

1、有氨基甾类肌松药使用禁忌症的患者; 2、肝/肾功能不全; 3、已知或怀疑患有神经肌肉疾病; 4、使用可能干扰神经肌肉传导的药物; 5、对布瑞亭或其他术中用全麻药过敏。 

Exclusion criteria:

1. Patients with contraindications for the use of aminosteroid muscle relaxants; 2. Patients with hepatic or renal dysfunction; 3. Known or suspected neuromuscular disease; 4. Taking medications that might influence the effect of NMB agents; 5. Allergy to Sugammadex or other General Anesthetics. 

研究实施时间:

Study execute time:

From2020-01-01To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2019-12-20To 2020-04-30 

干预措施:

Interventions:

组别:

A

样本量:

50

Group:

A

Sample size:

干预措施:

按实际体重用药

干预措施代码:

Intervention:

Medication according to total body weight

Intervention code:

组别:

B

样本量:

50

Group:

B

Sample size:

干预措施:

按校正体重用药

干预措施代码:

Intervention:

Medication according to corrected body weight

Intervention code:

组别:

B

样本量:

50

Group:

B

Sample size:

干预措施:

按校正体重用药

干预措施代码:

Intervention:

Medication according to corrected body weight

Intervention code:

组别:

C

样本量:

25

Group:

C

Sample size:

干预措施:

不用药

干预措施代码:

Intervention:

No medication

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

TOF值达到0.9的时间

指标类型:

主要指标 

Outcome:

The time of TOF ratio to 0.9

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TOF值达到0.8的时间

指标类型:

次要指标 

Outcome:

The time of TOF ratio to 0.8

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TOF值达到0.7的时间

指标类型:

次要指标 

Outcome:

The time of TOF ratio to 0.8

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

所有不良事件

指标类型:

主要指标 

Outcome:

All adverse events

Type:

Primary 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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

SPSS随机数表法

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

Random number will be generated by SPSS

盲法:

未说明

Blinding:

Not stated

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):

网络平台:ResMan (www.medresman.org)

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

web-based public database ResMan

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-29
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