Today is 2022-05-21

Effect of perioperative intravenous lidocaine on postoperative recovery after radical surgery for advanced colon cancer: a prospective, randomized, double-blind, placebo-controlled pilot trial
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注册号:

Registration number:

ChiCTR2200055937 

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:

围术期静脉使用利多卡因对进展期结肠癌根治术后恢复的影响:一项前瞻性、随机、双盲、安慰剂对照的预试验 

Public title:

Effect of perioperative intravenous lidocaine on postoperative recovery after radical surgery for advanced colon cancer: a prospective, randomized, double-blind, placebo-controlled pilot trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

围术期静脉使用利多卡因对进展期结肠癌根治术后恢复的影响:一项前瞻性、随机、双盲、安慰剂对照的预试验 

Scientific title:

Effect of perioperative intravenous lidocaine on postoperative recovery after radical surgery for advanced colon cancer: a prospective, randomized, double-blind, placebo-controlled pilot trial 

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:

彭科 

研究负责人:

彭科 

Applicant:

Ke Peng 

Study leader:

Ke Peng 

申请注册联系人电话:

Applicant telephone:

+8615962155989 

研究负责人电话:

Study leader's telephone:

+8615962155989 

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:

pengke0422@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pengke0422@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:

江苏省苏州市十梓街188号 

研究负责人通讯地址:

江苏省苏州市十梓街188号 

Applicant address:

188 Shizi Street, Suzhou, Jiangsu, China 

Study leader's address:

188 Shizi Street, Suzhou, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

215006 

研究负责人邮政编码:

Study leader's postcode:

215006 

申请人所在单位:

苏州大学附属第一医院 

Applicant's institution:

First Affiliated Hospital of Soochow 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伦审第936号 

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:

苏州大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of the First Affiliated Hospital of Soochow 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:

吴霜杰 

Contact Name of the ethic committee:

Shuangjie Wu 

伦理委员会联系地址:

中国江苏省苏州市平海路899号 

Contact Address of the ethic committee:

899 Pinghai Road, Suzhou, Jiangsu, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

0512-67972743 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

0512-67972743 

研究实施负责(组长)单位:

苏州大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

中国江苏省苏州市十梓街188号 

Primary sponsor's address:

188 Shizi Street, Suzhou, Jiangsu, 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):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州大学附属第一医院

具体地址:

姑苏区十梓街188号

Institution
hospital:

First Affiliated Hospital of Soochow University

Address:

188 Shizi Street, Gusu District

经费或物资来源:

研究者自筹 

Source(s) of funding:

Self-funded by the researcher  

研究疾病:

进展期结肠肿瘤手术预后 

Target disease:

Outcomes of advanced colon cancer surgery 

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:

探索性研究/预试验 

Study phase:

研究目的:

围术期静脉使用利多卡因对进展期结肠癌患者根治术后恢复的影响 

Objectives of Study:

To investigate the effects of perioperative intravenous lidocaine on postoperative recovery after radical surgery for advanced colon cancer 

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:

年龄≥18岁,ASA I~III级,拟在择期全身麻醉下行进展期结肠癌根治术的患者 

Inclusion criteria

Age ≥18 years, ASA status I~III, scheduled to undergo elective radical surgery for advanced colon cancer under general anesthesia 

排除标准:

既往或者共存的恶性肿瘤,心梗或脑血管事件病史,肾衰,肝功能不全,癫痫,传导阻滞,对利多卡因过敏 

Exclusion criteria:

previous or concurrent malignancy, history of myocardial infarction or cerebrovascular accident, renal failure, liver insufficiency,epilepsy, heart block, and allergy to lidocaine. 

研究实施时间:

Study execute time:

From2022-02-11To 2022-08-31 

征募观察对象时间:

Recruiting time:

From2022-02-11To 2022-08-31 

干预措施:

Interventions:

组别:

利多卡因组

样本量:

30

Group:

lidocaine

Sample size:

干预措施:

利多卡因

干预措施代码:

Intervention:

lidocaine

Intervention code:

组别:

安慰剂组

样本量:

30

Group:

placebo

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

normal saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

利多卡因血浆浓度

指标类型:

主要指标 

Outcome:

plasma concentration of lidocaine

Type:

Primary indicator 

测量时间点:

手术结束

测量方法:

Measure time point of outcome:

end of surgery

Measure method:

指标中文名:

术后恢复

指标类型:

次要指标 

Outcome:

recovery from surgery

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 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):

一名不参与后续研究的助理人员,使用在线随机化工具,以1:1的比例生成随机化

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

A research assistant who is not involved in the subsequent study will generate two randomized groups with the ratio of 1:1 by using an online randomization tool

盲法:

Blinding:

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):

公开发表的学术论文中公布

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

Published in a publicly published academic paper

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:

纸质材料及电子材料保存在苏州大学附属第一医院

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

The paper materials and electronic materials are kept in The First Affiliated Hospital of Soochow University

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-26
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