Today is 2022-05-21

Effect of Lidocaine Intraoperative Infusion on Postoperative Renal Function in Patients Undergoing Partial Nephrectomy
download

注册号:

Registration number:

ChiCTR2200055935 

最近更新日期:

Date of Last Refreshed on:

2022-01-26 

注册时间:

Date of Registration:

2022-01-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

利多卡因术中泵注对肾部分切除术患者术后肾功能的影响 

Public title:

Effect of Lidocaine Intraoperative Infusion on Postoperative Renal Function in Patients Undergoing Partial Nephrectomy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利多卡因术中泵注对肾部分切除术患者术后肾功能的影响:一项随机、对照、双盲的前瞻性研究  

Scientific title:

Effect of Lidocaine Intraoperative Infusion on Postoperative Renal Function in Patients Undergoing Partial Nephrectomy:a randomized, controlled, double-blinded prospective study  

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:

上官王宁 

研究负责人:

上官王宁 

Applicant:

Wangning Shangguan 

Study leader:

Wangning Shangguan 

申请注册联系人电话:

Applicant telephone:

+86 13587637891 

研究负责人电话:

Study leader's telephone:

+86 13587637891 

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:

sgwning@163.com 

研究负责人电子邮件:

Study leader's E-mail:

sgwning@163.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:

中国浙江温州市龙湾区温州大道1111号 

研究负责人通讯地址:

中国浙江温州市龙湾区温州大道1111号 

Applicant address:

1111 Wenzhou Road, Longwan District, Wenzhou, Zhejiang, China  

Study leader's address:

1111 Wenzhou Road, Longwan District, Wenzhou, Zhejiang, 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:

温州医科大学附属第二医院育英儿童医院 

Applicant's institution:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou 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:

2021-K-111-02 

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:

温州医科大学附属第二医院育英儿童医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-11-12 

伦理委员会联系人:

林振浪 

Contact Name of the ethic committee:

Zhenlang Lin 

伦理委员会联系地址:

中国浙江温州市龙湾区温州大道1111号 

Contact Address of the ethic committee:

1111 Wenzhou Road,Longwan District,Wenzhou,Zhejiang,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:

温州医科大学附属第二医院育英儿童医院 

Primary sponsor:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

中国浙江温州市龙湾区温州大道1111号 

Primary sponsor's address:

1111 Wenzhou Road, Longwan District, Wenzhou, Zhejiang, 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):

浙江

市(区县):

温州

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属第二医院育英儿童医院

具体地址:

中国浙江温州市龙湾区温州大道1111号

Institution
hospital:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Address:

1111 Wenzhou Road,Longwan District,Wenzhou,Zhejiang,China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

肾脏肿瘤 

Target disease:

tumor of kidney 

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:

评估术中静脉泵注利多卡因对肾脏部分切除术患者术后肾功能的影响。 

Objectives of Study:

To investigate the effect of intraoperative intravenous lidocaine infusion on postoperative renal function in patients undergoing partial nephrectomy. 

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岁≤年龄≤70岁;(2)择期行腹腔镜下肾脏部分切除术;(3)ASA I或II级;(4)签署知情同意书。  

Inclusion criteria

(1) Aged 18-70 years old;(2) Elective partial nephrectomy;(3) ASA I or II; (4) Sign informed consent.  

排除标准:

(1)术中改变术式;(2)局部麻醉药过敏史;(3)充血性心力衰竭;(4)严重心律失常;(5)肝功能肾功能严重障碍者;(6)既往肾脏手术史;(7)术中输血;;(8)慢性肾脏疾病史等。 

Exclusion criteria:

(1)The surgical procedure changed;(2)History of allergy to local anesthetics;(3) Congestive heart failure;(4) Severe arrhythmia; (5)Liver or renal dysfunctions;(6)History of renal surgery;(7)Intraoperative blood transfusion;(8)Chronic kidney disease,etc.  

研究实施时间:

Study execute time:

From2021-12-20To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2022-01-26To 2022-09-30 

干预措施:

Interventions:

组别:

利多卡因组

样本量:

25

Group:

Experimental group

Sample size:

干预措施:

利多卡因诱导、术中泵注

干预措施代码:

Intervention:

Lidocaine intraoperative infusion

Intervention code:

组别:

对照组

样本量:

25

Group:

Control group

Sample size:

干预措施:

相同容量生理盐水输注

干预措施代码:

Intervention:

Same volume normal saline intraoperative infusion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属第二医院育英儿童医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

估算的肾小球滤过率

指标类型:

主要指标 

Outcome:

eGFR

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:

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 18 years
最大 Max age 70 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):

由研究小组外的人通过一个计算机程序(random.org)执行,该程序生产一个从1到50的随机数序列,分为两列。

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

Member outside of the research group carries out through a computer program (random.org) that generates a random number sequence from 1 to 50, divided into two columns.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

中国临床试验注册中心

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

Chinese clinica ltrial registry

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:

Case Record Form, CRF

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:

 2022-01-26
return list