今天是:2019-04-22 星期一

舒更葡糖钠应用于3岁以下儿童手术后逆转罗库溴铵神经肌肉阻滞的群体药动学/药效学研究
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注册号:

Registration number:

ChiCTR1900022542 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

舒更葡糖钠应用于3岁以下儿童手术后逆转罗库溴铵神经肌肉阻滞的群体药动学/药效学研究 

Public title:

Population pharmacokinetic/pharmacodynamic study of sugammadex for reversing rocuronium neuromuscular block after surgery in children under 3 years old 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

舒更葡糖钠应用于3岁以下儿童手术后逆转罗库溴铵神经肌肉阻滞的群体药动学/药效学研究 

Scientific title:

Population pharmacokinetic/pharmacodynamic study of sugammadex for reversing rocuronium neuromuscular block after surgery in children under 3 years old 

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:

黄俊祥 

研究负责人:

李碧莲 

Applicant:

Huang Junxiang 

Study leader:

Libilian 

申请注册联系人电话:

Applicant telephone:

+86 15800044945 

研究负责人电话:

Study leader's telephone:

+86 13570226780 

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:

hanzhugg@126.com 

研究负责人电子邮件:

Study leader's E-mail:

32417024@qq.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:

广东省广州市越秀区人民中路318号 

研究负责人通讯地址:

广东省广州市越秀区人民中路318号 

Applicant address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, 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:

广州市妇女儿童医疗中心 

Applicant's institution:

Guangzhou Women and Children Medical Center 

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:

23301 

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:

广州市妇女儿童医疗中心科研伦理委员会 

Name of the ethic committee:

Guangzhou Women and Children's Medical Center Institutional Review Board  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-10 

伦理委员会联系人:

蔡思勉 

Contact Name of the ethic committee:

Simian Cai 

伦理委员会联系地址:

广州市金穗路9号 

Contact Address of the ethic committee:

9 Jinsui Road, Guangzhou, Guangdong, 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:

广州市妇女儿童医疗中心 

Primary sponsor:

Guangzhou Women and Children's Medical Center 

研究实施负责(组长)单位地址:

广州市人民中路318号 

Primary sponsor's address:

318 Renmin Middle Road, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州市妇女儿童医疗中心

具体地址:

广东省广州市人民中路318号

Institution
hospital:

Guangzhou Women and Children Medical Center

Address:

318 Renmin Middle Road, Guangzhou, Guangdong, China

经费或物资来源:

吴阶平医学基金会 

Source(s) of funding:

Wu Jieping Medical Foundation  

研究疾病:

儿童手术麻醉的神经阻滞 

Target disease:

Neuromuscular block for surgical anesthesia in children  

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:

建立sugammadex应用于逆转3岁以下儿童手术神经肌肉阻滞的群体药动学/药效学模型 

Objectives of Study:

To establish a population pharmacokinetic/pharmacodynamic model of sugammadex for reversing neuromuscular blockade in children under 3 years of age 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

不同剂量对照 

Study design:

Dose comparison 

纳入标准:

(1)日间手术的患者行气管内插管或喉罩通气的病人; (2)年龄在3个月-3岁儿童; (3)术中使用单剂量罗库溴铵,术后使用舒更葡糖逆转罗库溴铵的NMB; (4)ASA分级Ⅰ-II级。 

Inclusion criteria

1. Patients undergoing endotracheal intubation or laryngeal mask ventilation during day surgery; 2. Children between the ages of 3 months and 3 years old; 3. intraoperative use of a single dose of rocuronium, postoperative use of sugammadex to reverse the neuromuscular block of rocuronium; 4. ASA grade I-II. 

排除标准:

(1)已知或潜在神经肌肉障碍; (2)使用与罗库溴铵药物相互作用的药物或影响神经-肌肉传导的药物; (3)营养不良或过度肥胖; (4)明显心 、肺疾病及肝 、肾功能异常; (5)对全身麻醉用药有过敏或恶性高热家族史患者; (6)有明显的心肺、血液学、内分泌或代谢胃肠道疾病的患者; 

Exclusion criteria:

(1) known or potential neuromuscular disorders; (2) using a drug that interacts with rocuronium or a drug that affects nerve-muscle conduction; (3) malnutrition or excessive obesity before surgery; (4) obvious heart, lung disease or abnormal liver and kidney function; (5) Patients with a family history of allergies or malignant hyperthermia for general anesthesia; (6) Patients with obvious cardiopulmonary, hematological, endocrine or metabolic gastrointestinal diseases. 

研究实施时间:

Study execute time:

From2019-04-15To 2021-12-31 

干预措施:

Interventions:

组别:

M组

样本量:

36

Group:

M Group

Sample size:

干预措施:

罗库溴铵和sugammadex 用于3岁以下儿童腹腔镜手术中度神经肌肉阻滞

干预措施代码:

Intervention:

Rocuronium and sugammadex for moderate neuromuscular block in laparoscopic surgery in children under 3 years old

Intervention code:

组别:

D组

样本量:

36

Group:

D Group

Sample size:

干预措施:

罗库溴铵和sugammadex 用于3岁以下儿童腹腔镜手术中度神经肌肉阻滞

干预措施代码:

Intervention:

Rocuronium and sugammadex for deep neuromuscular block in laparoscopic surgery in children under 3 years old

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

肌松效应

指标类型:

主要指标 

Outcome:

Muscle relaxant effect

Type:

Primary indicator 

测量时间点:

罗库溴铵给药后

测量方法:

肌松监测仪

Measure time point of outcome:

After administration of rocuronium

Measure method:

Muscle relaxant monitor

指标中文名:

TOFr恢复时间

指标类型:

主要指标 

Outcome:

TOFr recovery time

Type:

Primary indicator 

测量时间点:

sugammadex给药后

测量方法:

肌松监测仪

Measure time point of outcome:

After administration of sugammadex

Measure method:

Muscle relaxant monitor

指标中文名:

罗库溴铵血药浓度

指标类型:

主要指标 

Outcome:

Rocuronium plasma concentration

Type:

Primary indicator 

测量时间点:

罗库溴铵给药后2min,10min,sugammadex给药前,给药后2min,10min,出PACU前

测量方法:

液质联用法

Measure time point of outcome:

2 min, 10 min after rocuronium administration, before sugammadex administration, 2 min, 10 min after sugammadex administration, before leaving PACU

Measure method:

UPLC-MS

指标中文名:

sugammadex血药浓度

指标类型:

主要指标 

Outcome:

sugammadex plasma concentration

Type:

Primary indicator 

测量时间点:

sugammadex给药后2min,10min,出PACU前

测量方法:

液质联用法

Measure time point of outcome:

2 min, 10 min after sugammadex administration, before leaving PACU

Measure method:

UPLC-MS

指标中文名:

生命体征

指标类型:

主要指标 

Outcome:

Vital signs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后疼痛

指标类型:

次要指标 

Outcome:

Postoperative pain

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术条件

指标类型:

次要指标 

Outcome:

surgical condition

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后不良反应

指标类型:

次要指标 

Outcome:

Postoperative adverse events

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:

标本中文名:

血液

组织:

Sample Name:

blood

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 0.3 years
最大 Max age 3 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):

电脑产生随机序列

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

computer-generated randomisation list

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

试验完成6个月内公开,有需求可向我们索取原始数据

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

Data will be shared within six months after the trial complete. Anyone can ask us for original data if needed

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:

数据收集管理使用病例记录表和电子采集和管理系统如临床研究公共管理平台(Research Manager, ResMan)

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

Data collection management using Case Record Form and electronic collection and management systems such as the Research Manager

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-16
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