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Effects of Sugammadex for the reversal of moderate neuromuscular blockade in patients during renal transplantation on graft function
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注册号:

Registration number:

ChiCTR2200055639 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理批件 舒更葡糖钠逆转肾移植手术中度神经肌肉阻滞的效果及其对肾功能的影响 

Public title:

Effects of Sugammadex for the reversal of moderate neuromuscular blockade in patients during renal transplantation on graft function 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

舒更葡糖钠逆转肾移植手术中度神经肌肉阻滞的效果及其对肾功能的影响 

Scientific title:

Effects of Sugammadex for the reversal of moderate neuromuscular blockade in patients during renal transplantation on graft function 

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:

唐轶洋 

研究负责人:

唐轶洋 

Applicant:

Tang Yiyang 

Study leader:

Tang Yiyang 

申请注册联系人电话:

Applicant telephone:

13751869517 

研究负责人电话:

Study leader's telephone:

13751869517 

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:

157769414@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

157769414@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大德路111号 

研究负责人通讯地址:

广东省广州市越秀区大德路111号 

Applicant address:

No.111 Yuexiu District, Guangzhou city, Guangdong Province 

Study leader's address:

No.111 Yuexiu District, Guangzhou city, Guangdong Province  

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:

广州中医药大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine  

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:

ZF2021-343-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Institutional Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-04 

伦理委员会联系人:

李晓彦 

Contact Name of the ethic committee:

Li Xiaoyan 

伦理委员会联系地址:

广东省广州市越秀区大德路111号 

Contact Address of the ethic committee:

No.111 Yuexiu District, Guangzhou city, Guangdong Province 

伦理委员会联系人电话:

Contact phone of the ethic committee:

0755-81887233转81543 

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:

广州中医药大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号 

Primary sponsor's address:

No.111 Yuexiu District, Guangzhou city, Guangdong Province 

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):

广东省中医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Hospital of Traditional Chinese Medicine

Address:

No.111 Yuexiu District, Guangzhou city, Guangdong Province

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

终末期肾病 

Target disease:

End-stage renal disease 

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:

探索舒更葡糖钠逆转肾移植手术患者中度神经肌肉阻滞的效果、安全性及其对肾功能恢复的影响,为终末期肾病患者提供更多的用药参考 

Objectives of Study:

To explore the effects of Sugammadex for the reversal of moderate neuromuscular blockade in patients during renal transplantation on graft function, and to provide more medication reference for patients with end-stage renal disease  

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)在全麻下急诊行肾移植手术的患者(肌酐清除率CLCR≤30ml/min) (2)年均龄在18-65岁 (3)ASA分级Ⅱ-Ⅲ级  

Inclusion criteria

(1)Patients undergo emergency renal transplantation under general anesthesia(CLCR≤30ml/min) (2)Patients age 18 to 65 (3)ASA glass Ⅱ-III  

排除标准:

(1)患有神经肌肉系统疾病,肝功能障碍,严重呼吸系统疾病和个人或家族有恶性高热史 (2)怀孕或哺乳期女性 (3)困难气道,呼吸睡眠暂停综合征和体重指数≥28kg/m2 (4)对麻醉药物、肌松剂及全麻期间使用的其他药物过敏 (5)近期服用过可以下药物患者:氨基糖苷类抗生素,抗惊厥药、镁剂,围术期服用托雷米芬、夫西地酸和氟氯西林 

Exclusion criteria:

Patients suffering obstructive sleep apnea hypopnea syndrome or BMI≥28kg/m2, those who were pregnant or breastfeeding women, or with neuromuscular disorders, hepatic dysfunction, severe respiratory disorders, a history of malignant hyperthermia, or allergy to narcotics, NMBAs or other medication used during general anaesthesia were excluded, as were patients receiving aminoglycoside antibiotics, anticonvulsants, magnesium, fusidic acid, toremifene and/or flucloxacillin 

研究实施时间:

Study execute time:

From2022-01-04To 2023-01-31 

征募观察对象时间:

Recruiting time:

From2022-01-05To 2023-01-31 

干预措施:

Interventions:

组别:

舒更葡糖那钠组(S组)

样本量:

26

Group:

sugammadex(S group)

Sample size:

干预措施:

当肌松监测仪校准后注射罗库溴铵0.6mg/kg,术中当T2出现时追加罗库溴铵0.15mg/kg,手术结束后当T2重现时,静脉注射舒更葡糖钠2mg/kg逆转神经肌肉阻

干预措施代码:

Intervention:

After calibration of the TOF-Watch SX, an i.v. bolus dose of rocuronium 0.6 mg/kg is given for tracheal intubation, with maintenance doses 0.15mg/kg if T2 reappears to maintain moderate NMB. Patients receive sugammadex 2 mg/kg i.v. for reversal when surgery finish and T2 reappears.

Intervention code:

组别:

新斯的明组(N组)

样本量:

26

Group:

Neostigmine(N group)

Sample size:

干预措施:

当肌松监测仪校准后注射罗库溴铵0.6mg/kg,术中当T2出现时追加罗库溴铵0.15mg/kg,手术结束后当T2重现时,静脉注射新斯的明0.05mg/kg+阿托品0.15mg/kg逆转神经肌肉阻

干预措施代码:

Intervention:

After calibration of the TOF-Watch SX, an i.v. bolus dose of rocuronium 0.6 mg/kg is given for tracheal intubation, with maintenance doses 0.15mg/kg if T2 reappears to maintain moderate NMB. Patients receive neostigmine 0.05 mg/kg+atropine 0.15 i.v. for reversal when surgery finish and T2 reappears.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

广东省中医院大学城分院麻醉科 

单位级别:

省级三甲 

Institution
hospital:

Anesthesiology department of University Town Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Provincial grade A hospital  

测量指标:

Outcomes:

指标中文名:

术后移植肾功能

指标类型:

主要指标 

Outcome:

Postoperative graft function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

开始给药至T4/T1比值恢复至0.9的平均时间

指标类型:

次要指标 

Outcome:

Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9

Type:

Secondary indicator 

测量时间点:

从舒更葡糖钠开始使用

测量方法:

通过TOF-Watch肌松监测仪获得

Measure time point of outcome:

The beginning of administration of Sugammadex

Measure method:

It is obtained by neuromuscular monitoring(TOF-Watch)

指标中文名:

研究对象≥1例不良事件(AE)的百分比

指标类型:

副作用指标 

Outcome:

Percentage of Participants With ≥1 Adverse Event (AE)

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌松残余

指标类型:

次要指标 

Outcome:

Residual neuromuscular block

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 smaple

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 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):

采用随机数字表进行随机,由一名研究助理(麻醉护士)进行随机分组并跟随患者入手术室,并在手术结束时配置研究药物,但不参与后期数据的收集

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

The process of randomisation was performed by a research assistant who also followed the patient into the operating surgery to administer the study drug at the end of surgery, but who was not further concerned with the collection of postoperative data.

盲法:

双盲,对受试者和参与手术的麻醉医生设盲

Blinding:

Double blind

是否共享原始数据:

IPD sharing

No

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):

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

none

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:

病历记录表,由研究负责人管理

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

Case Record Form The study leader is in charge

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-01-15
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