今天是:2019-11-17 星期日

李于鑫医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 米库氯铵麻醉诱导后最佳气管插管时机的随机对照研究
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注册号:

Registration number:

ChiCTR1900026781 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2019-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

李于鑫医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 米库氯铵麻醉诱导后最佳气管插管时机的随机对照研究 

Public title:

Randomized controlled study of tracheal intubation condition at different time point after mivacurium injection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

米库氯铵麻醉诱导后最佳气管插管时机的随机对照研究 

Scientific title:

Randomized controlled study of tracheal intubation condition at different time point after mivacurium injection 

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:

李于鑫 

研究负责人:

张晓光 

Applicant:

Yuxin Li 

Study leader:

Xiaoguang Zhang 

申请注册联系人电话:

Applicant telephone:

+86 15800951219 

研究负责人电话:

Study leader's telephone:

+86 13641995733 

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:

yuxinlee121@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangxg@fudan.edu.cn 

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:

上海市徐汇区枫林路180号 

研究负责人通讯地址:

上海市徐汇区枫林路180号 

Applicant address:

180 Fenglin Road, Xuhui District, Shanghai, China 

Study leader's address:

180 Fenglin Road, Xuhui District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200032 

研究负责人邮政编码:

Study leader's postcode:

200032 

申请人所在单位:

复旦大学附属中山医院 

Applicant's institution:

Zhongshan Hospital of Fudan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

复旦大学附属中山医院麻醉科 

Primary sponsor:

Department of Anesthesiology,Zhongshan Hospital of Fudan University 

研究实施负责(组长)单位地址:

上海市徐汇区枫林路180号 

Primary sponsor's address:

180 Fenglin Road, Xuhui District, Shanghai, 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):

上海市

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

复旦大学附属中山医院

具体地址:

枫林路180号

Institution
hospital:

Zhongshan Hospital of Fudan University

Address:

180 Fenglin Road

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

气管插管 

Target disease:

Tracheal intubation 

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:

比较米库氯铵给药完毕后90s和180s后行气管插管的插管条件,为临床更加合理使用米库氯铵提供依据。 

Objectives of Study:

To compare the intubation conditions 90s or 180s after mivacurium injection, as to optimize the use of mivacurium in clinic. 

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. 气管插管全身麻醉下行短小手术(预计手术时间<1h)患者; 2. 年龄18~65岁; 3. 美国麻醉医师协会(American Society of Anesthesiologists,ASA)分级I-II级; 4. Mallampati气道评级为 I-II级; 5. 签署知情同意书。 

Inclusion criteria

1. Patients scheduled for short time operation under general anesthesia with tracheal intubation(estimated operation time <1h); 2. aged 18-65 years; 3. American Society of Anesthesiologists (ASA) grade I-II; 4. Mallampati airway grade I-II; 5. Signed informed consent. 

排除标准:

1. 长期大量吸烟、酗酒、药物滥用和精神疾病患者; 2. 严重呼吸系统疾病、COPD、哮喘、气道高反应; 3. 严重心血管疾病,如冠心病、严重瓣膜病等; 4. 肝肾功能异常; 5. 严重电解质平衡紊乱; 6. 神经肌肉系统疾病,一周内使用过神经肌肉松阻滞剂的患者,近期使用干扰神经肌肉兴奋传导的药物如抗癫痫药、激素、呋塞米、氨基糖苷类抗生素等; 7. 张口度<3指,颈部活动度异常,颏甲距离<6 cm,困难气道者; 8. 反流误吸高风险者; 9. 既往对米库氯铵或其他肌松药过敏者; 10. 已知血浆胆碱酯酶缺乏症; 11. 女性妊娠期或哺乳期; 12. 研究开始前30日内参加过任何药物临床试验的患者; 13. 研究者认为有不适合入选的其他情况。 

Exclusion criteria:

1. Heavy long-term smokers, alcoholics, drug addicts and mental disorder patients; 2. Severe respiratory system diseases, COPD, asthma, hyperresponsive airway condition; 3. Severe cardiovascular system diseases, such as coronary heart disease, severe valvular heart disease, etc. 4. Abnormal liver and kidney function; 5. Serious electrolyte imbalance; 6. Neuromuscular diseases, patients who have used neuromuscular blockers within one week, patients who have recently used medicine that interfere with neuromuscular excitation conduction, such as antiepileptics, hormones, furosemide, aminoglycoside antibiotics, etc; 7. Mouth opening less than 3 fingers, abnormal neck movement, chin nail distance less than 6cm, difficult airway; 8. High risk of aspiration; 9. Previous allergy to mivacurium or other muscle relaxants; 10. Known plasma cholinesterase deficiency; 11. During pregnancy or lactation; 12. Patients who have participated in any other drug clinical trials within 30 days before the start of the study; 13. Other conditions not suitable for inclusion. 

研究实施时间:

Study execute time:

From2019-11-01To 2020-12-31 

干预措施:

Interventions:

组别:

90s组

样本量:

38

Group:

90s group

Sample size:

干预措施:

注射完米库氯铵90s后行气管插管

干预措施代码:

Intervention:

Tracheal intubation 90 s after mivacurium injection

Intervention code:

组别:

180s组

样本量:

38

Group:

180s group

Sample size:

干预措施:

注射完米库氯铵180s后行气管插管

干预措施代码:

Intervention:

Tracheal intubation 180 s after mivacurium injection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui District 

单位(医院):

复旦大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan Hospital of Fudan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

每组患者插管条件评级为优的比例

指标类型:

主要指标 

Outcome:

Proportion of patients in each group with excellent intubation condition

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均动脉压

指标类型:

次要指标 

Outcome:

MAP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

次要指标 

Outcome:

HR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血氧饱和度

指标类型:

次要指标 

Outcome:

SpO2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤潮红

指标类型:

次要指标 

Outcome:

Skin flushing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部哮鸣音

指标类型:

次要指标 

Outcome:

lung wheezing rale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Cormack-Lehane分级

指标类型:

次要指标 

Outcome:

Cormack-Lehane grade

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Cooper’s气管插管评分各分项得分

指标类型:

次要指标 

Outcome:

Cooper 's tracheal intubation scores

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 65 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):

研究负责人根据计算机产生的随机数字表随机分配。

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

The researchers randomly assign according to the random number table generated by the computer.

盲法:

双盲。进行气管插管操作以及气管插管条件评级的研究者在麻醉诱导给药过程中于手术室外等候,待气管插管时进入手术室完成气管插管,插管完成后立即进行气管插管条件评级,以保证该研究者不了解分组情况。麻醉诱导以及诱导阶段各项指标的记录由另外一名研究者完成。

Blinding:

Double blind.

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):

联系实验者公开,本研究完成后原始数据将于本注册中心公开

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

contact with the leader,data sharing will be able to access in ChiCTR after the trial complete

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:

采用临床试验公共管理平台进行记录和管理

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

The data will be recorded and managed by ChiCTR

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-22
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