今天是:2019-12-07 星期六

代元强医师:该研究的伦理审批文件未上传,请尽快上传并填写伦理审批日期、伦理委员会联系人。 不同神经阻滞方案合并全身麻醉对胰腺癌术中血流动力学影响及预后的研究
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注册号:

Registration number:

ChiCTR1900026786 

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:

代元强医师:该研究的伦理审批文件未上传,请尽快上传并填写伦理审批日期、伦理委员会联系人。 不同神经阻滞方案合并全身麻醉对胰腺癌术中血流动力学影响及预后的研究 

Public title:

Effects of different nerve block and general anesthesia on hemodynamics and prognosis of pancreatic cancer during operation  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同神经阻滞方案合并全身麻醉对胰腺癌术中血流动力学影响及预后的研究 

Scientific title:

Effects of different nerve block and general anesthesia on hemodynamics and prognosis of pancreatic cancer during operation  

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:

代元强 

研究负责人:

许涛 

Applicant:

Dai Yuanqiang 

Study leader:

Xu Tao 

申请注册联系人电话:

Applicant telephone:

+86 18217096874 

研究负责人电话:

Study leader's telephone:

+86 13501976460 

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:

413650671@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

taoxu_smmu@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:

上海市杨浦区长海路168号长海医院6号楼14楼麻醉科 

研究负责人通讯地址:

上海市杨浦区长海路168号长海医院6号楼14楼麻醉科  

Applicant address:

168 Changhai Road, Yangpu District, Shanghai, China  

Study leader's address:

168 Changhai Road, Yangpu District, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

200433 

研究负责人邮政编码:

Study leader's postcode:

200433 

申请人所在单位:

上海长海医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Shanghai Changhai Hospital 

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:

CHEC2019-195 

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:

长海医院伦理委员会 

Name of the ethic committee:

Changhai Hospital Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

上海市杨浦区长海路168号 

Contact Address of the ethic committee:

168 Changhai Road, Yangpu District, Shanghai, 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:

上海长海医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Shanghai Changhai Hospital  

研究实施负责(组长)单位地址:

上海市杨浦区长海路168号 

Primary sponsor's address:

168 Changhai Road, Yangpu 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):

杨浦区

Country:

China

Province:

Shanghai

City:

Yangpu District

单位(医院):

上海长海医院

具体地址:

杨浦区长海路168号

Institution
hospital:

Shanghai Changhai Hospital

Address:

168 Changhai Road, Yangpu District

经费或物资来源:

无 

Source(s) of funding:

no 

研究疾病:

胰腺癌 

Target disease:

pancreatic cancer 

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:

研究不同神经阻滞方案合并全身麻醉对胰腺癌术中血流动力学影响及预后。 

Objectives of Study:

To study the effect of different nerve block and general anesthesia on hemodynamics and prognosis of pancreatic cancer during operation. 

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)ASA分级:I、II级; 2)年龄18-70岁; 3)胰腺手术。 

Inclusion criteria

1) ASA classification: I, II; 2) aged 18-70 years; 3) pancreatic surgery. 

排除标准:

1)术前放疗、化疗的患者; 2)有慢性疼痛病史,术前使用镇痛剂的患者; 3)术前接受激素或类固醇治疗; 4)既往有神经肌肉系统疾病; 5)既往认知功能障碍; 6)有椎旁阻滞禁忌症(严重的凝血功能障碍、感染或局麻药过敏史); 7)18.5≥BMI≥30kg/m2; 8)器质性心脏病或严重心律失常者; 9)急诊手术; 10)再次上腹部手术患者; 11)拒绝参加。 

Exclusion criteria:

1) patients with preoperative radiotherapy and chemotherapy; 2) patients who have a history of chronic pain and use analgesics before operation; 3) preoperative hormone or steroid therapy; 4) previous neuromuscular diseases; 5) previous cognitive impairment; 6) contraindications of paravertebral block (severe coagulation dysfunction, infection or local anesthetic allergy history); 7) 18.5 >= BMI >= 30kg / m2; 8) organic heart disease or serious arrhythmia; 9) emergency operation; 10) patients undergoing upper abdominal surgery again; 11) refusal to participate.  

研究实施时间:

Study execute time:

From2019-11-01To 2020-04-30 

干预措施:

Interventions:

组别:

试验高浓度组(H组)

样本量:

36

Group:

Group H

Sample size:

干预措施:

椎旁注射0.5%罗哌卡因

干预措施代码:

Intervention:

Paravertebral Injection of 0.5% ropivacaine

Intervention code:

组别:

试验低浓度组(L组)

样本量:

36

Group:

Group L

Sample size:

干预措施:

椎旁注射0.25%罗哌卡因

干预措施代码:

Intervention:

Paravertebral Injection of 0.25% ropivacaine

Intervention code:

组别:

对照组(T组)

样本量:

36

Group:

Group T

Sample size:

干预措施:

腹横筋膜阻滞+腹直肌后鞘阻滞

干预措施代码:

Intervention:

TAP+RSB

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):

杨浦区 

Country:

China 

Province:

Shanghai 

City:

Yangpu District 

单位(医院):

上海长海医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Changhai Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血流动力学

指标类型:

主要指标 

Outcome:

Hemodynamics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者手术预后

指标类型:

次要指标 

Outcome:

Surgical prognosis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症的发生率

指标类型:

次要指标 

Outcome:

Incidence of complications

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 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):

由研究团队中一名麻醉医生运用简单随机化,制定随机分组表,纳入研究的对象通过随机分组表决定归属。

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

Using simple randomization, an anesthesiologist in the research team developed a random grouping table, and the subjects included in the study decided to belong through the random grouping table.

盲法:

双盲

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):

试验完成后6月内公开

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

within six months after the trial compiete

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-22
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