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Hydromorphine via HO-1 upregulation improves the balance of mitochondrial dynamics and alleviate CO2 pneumoperitoneum related lung injury
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注册号:

Registration number:

ChiCTR-IOR-17011733 

最近更新日期:

Date of Last Refreshed on:

2017-06-21 

注册时间:

Date of Registration:

2017-06-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

氢吗啡酮通过调节HO-1表达改善线粒体动力学平衡从而减轻二氧化碳气腹肺损伤 

Public title:

Hydromorphine via HO-1 upregulation improves the balance of mitochondrial dynamics and alleviate CO2 pneumoperitoneum related lung injury 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

氢吗啡酮通过调节HO-1表达改善线粒体动力学平衡从而减轻二氧化碳气腹肺损伤 

Scientific title:

Hydromorphine via HO-1 upregulation improves the balance of mitochondrial dynamics and alleviate CO2 pneumoperitoneum related lung injury 

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:

史佳 

研究负责人:

余剑波 

Applicant:

Shi Jia 

Study leader:

Yu Jianbo 

申请注册联系人电话:

Applicant telephone:

+86 13652033134 

研究负责人电话:

Study leader's telephone:

+86 13652033134 

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:

steadysj@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

yujianbo11@126.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:

天津市南开区长江道6号 

研究负责人通讯地址:

天津市南开区长江道6号 

Applicant address:

6 Changjiang road, Nankai district, Tianjin, China 

Study leader's address:

6 Changjiang road, Nankai district, Tianjin, 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:

天津市南开医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Tianjin Nankai 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:

2017-007P 

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:

天津市南开医院伦理委员会 

Name of the ethic committee:

Ethic Committe of Tianjin Nankai Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-02-24 

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:

天津市南开医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Tianjin Nankai Hospital 

研究实施负责(组长)单位地址:

天津市南开区长江道6号 

Primary sponsor's address:

6 Changjiang road, Nankai district, Tianjin, 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):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市南开医院

具体地址:

天津市南开区长江道6号

Institution
hospital:

Tianjin Nankai Hospital

Address:

6 Changjiang road, Nankai district, Tianjin, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

经腹腔镜全子宫切除手术治疗的患者 

Target disease:

Patients undergoing laparoscopic total hysterectomy 

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:

探讨氢吗啡酮通过调节HO-1表达改善线粒体动力学平衡从而减轻CO2气腹相关性肺损伤,为氢吗啡酮减轻CO2气腹相关性肺损伤提供理论依据,为氢吗啡酮的临床应用奠定基础 

Objectives of Study:

To test the hypothesis that hydromorphine via HO-1 upregulation improves the balance of mitochondrial dynamics and alleviate CO2 pneumoperitoneum related lung injury 

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:

选取择期行全身麻醉下经腹腔镜全子宫切除手术治疗的女性患者,ASA I~II级,年龄在30-65岁,体重40-70kg,所有患者均无慢性疼痛病史、精神病史和长期服用镇痛类药物病史 

Inclusion criteria

Women aged 30-65 yearsweighed 40-70kg with ASA status I or II, scheduled for elective laparoscopic total hysterectomy of<3h duration at Tianjin Nankai hospital between June 2017 and March 2018 were enrolled in this study. All patients have no history of chronic pain, mental illness, and a long-term history of pain reliever. 

排除标准:

既往有阿片类/NSAIDS药物应用史、哮喘病史、精神类疾病史、严重心肺疾病史、严重肝肾疾病史及手术时间>3h 

Exclusion criteria:

Exclusion criteria included cardiovascular disease (hypertension, arrhythmia or myocardial ischaemia), haemodynamic instability (active bleeding, hypovolaemia or loss of body fluid), asthma or chronic obstructive pulmonary disease, allergy to the study drug and body mass index < 16 or > 30 kg/m2. 

研究实施时间:

Study execute time:

From2017-02-24To 2018-03-01 

征募观察对象时间:

Recruiting time:

From2017-06-26To 2018-03-01 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

氢吗啡酮治疗

干预措施代码:

Intervention:

hydromorphine treatment

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

七氟醚全凭吸入麻醉

干预措施代码:

Intervention:

Sevoflurane relies on inhalation anesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津市 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市南开医院 

单位级别:

三级 

Institution
hospital:

Tianjin Nankai Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肺动态顺应性

指标类型:

主要指标 

Outcome:

Cdyn

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸指数

指标类型:

主要指标 

Outcome:

RI

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:

动脉血

组织:

Sample Name:

arterial 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 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由统计老师利用统计软件产生随机数字,随机方法为区组随机,按照1:1的比例将入组患者分为2组,本研究为标签开放的随机对照研究。

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

An anaesthetist not involved in patient anaesthetic management held the randomization codes until the end of the study. Another anaesthetist, who was not involved with postoperative patient evaluation and was blinded to group allocation, conducted the course of anaesthesia. Patients and the anaesthetists in charge were

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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):

上传到ResMan临床试验公共管理平台 Clinical Trial Management Public Platform

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

Upload the data to the Clinical Trial Management Public Platform of ResMan

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:

本研究采用纸质数据采集方式进行数据管理。研究者根据受试者的原始观察记录,将数据及时、完整、正确的写入病例报告表。数据录入和管理工作委托第三方数据管理人员执行。采用EpiData3.10数据库系统进行双人双遍录入。比对完成后,由数据 管理员利用SAS9.2软件进行数据核查,将核查出的问题以及录入过程中遇到的问题或意外情况总结归纳成疑问表,交由研究者 解答,直至无数据问题存在。

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

The methods of paper data collection are used for data management.Using the EpiData3.10 database system for double-time entry.The USES SAS9.2 software is applied for data verification by data administrator.

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:

 2017-06-21
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