今天是:2019-06-24 星期一

甲氧明联合目标导向液体治疗在老年患者行胃肠肿瘤手术中的应用研究
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注册号:

Registration number:

ChiCTR1900022528 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

甲氧明联合目标导向液体治疗在老年患者行胃肠肿瘤手术中的应用研究 

Public title:

Methoxamine combined GDFT in elderly patients with gastrointestinal neoplasms undergoing surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

甲氧明联合目标导向液体治疗在老年患者行胃肠肿瘤手术中的应用研究 

Scientific title:

Methoxamine combined GDFT in elderly patients with gastrointestinal neoplasms undergoing surgery 

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:

陈莹莹 

研究负责人:

张宗泽 

Applicant:

Chen Yingying 

Study leader:

Zhang Zongze 

申请注册联系人电话:

Applicant telephone:

+86 13476119947 

研究负责人电话:

Study leader's telephone:

+86 13971687403 

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:

chenyingy@whu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhangzz@whu.edu.cn 

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:

湖北省武汉市东湖路169号 

研究负责人通讯地址:

湖北省武汉市东湖路169号 

Applicant address:

169 East Lake Road, Wuhan, Hubei, China 

Study leader's address:

169 East Lake Road, Wuhan, Hubei, 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:

武汉大学中南医院 

Applicant's institution:

Zhongnan Hospital, Wuhan 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:

2016023 

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:

武汉大学中南医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Zhongnan Hospital, Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-09-02 

伦理委员会联系人:

郑磊 

Contact Name of the ethic committee:

Zheng Lei 

伦理委员会联系地址:

湖北省武汉市东湖路169号 

Contact Address of the ethic committee:

East Lake Road, Wuhan, Hubei, 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:

武汉大学中南医院 

Primary sponsor:

Zhongnan Hospital, Wuhan University 

研究实施负责(组长)单位地址:

湖北省武汉市东湖路169号 

Primary sponsor's address:

169 East Lake Road, Wuhan, Hubei, 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):

湖北省

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院

具体地址:

东湖路169号

Institution
hospital:

Zhongnan Hospital, Wuhan University,

Address:

169 East Lake Road

经费或物资来源:

湖北省卫生健康委员会联合基金项目(WJ2019H085) 

Source(s) of funding:

Joint Fund Project of Hubei Health Commission (WJ2019H085) 

研究疾病:

胃肠道肿瘤 

Target disease:

gastrointestinal neoplasms 

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:

评价甲氧明联合目标导向液体治疗在老年患者行胃肠道肿瘤手术中的应用。 

Objectives of Study:

To evaluate the application of methoxamine combined with GDFT in elderly patients with gastrointestinal neoplasms undergoing surgery. 

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.年龄65~85周岁,男女不限; 2.BMI指数18kg/m2~30kg/m2之间; 3.在全麻下胃肠道肿瘤手术; 4.ASA分级为II级或III级; 5.预计住院观察治疗时间≥72h; 6.签署知情同意书。 

Inclusion criteria

1. Aged 65-85 years, male of female. 2 BMI index is between 18kg/m and 30kg/m. 3. Gastrointestinal cancer surgery under general anesthesia; 4. Patients with ASA grade II or III; 5. Hospitalization observation and treatment time is expected to be more than 72 hours. 6. Sign informed consent. 

排除标准:

1.体重<40kg; 2.静脉输注障碍; 3.器质性心脏病,如主动脉重度关闭不全; 4.高出血风险患者,如血友病、血小板减少、血小板功能异常; 5.严重高血压未经控制,或者术前6h内使用过降压药物,血压仍高于140/90mmHg; 6.青光眼患者; 7.抑郁症患者,如两周内曾用过单胺氧化酶抑制剂患者。 

Exclusion criteria:

1. Body weight < 40kg; 2. Intravenous infusion disorder; 3. Organic heart disease, such as severe aortic insufficiency; 4. Patients at high risk of bleeding, such as hemophilia, thrombocytopenia and abnormal platelet function; 5. The blood pressure was still higher than 140/90 mmHg when severe hypertension was uncontrolled or over-antihypertensive drugs were used within 6 hours before operation. 6. Glaucoma patients; 7. Depressive patients, such as those who have used monoamine oxidase inhibitors in two weeks. 

研究实施时间:

Study execute time:

From2019-05-01To 2019-09-01 

干预措施:

Interventions:

组别:

经典输液治疗组

样本量:

20

Group:

Group C

Sample size:

干预措施:

经典输液治疗

干预措施代码:

Intervention:

Classical infusion therapy

Intervention code:

组别:

甲氧明组

样本量:

20

Group:

Group M

Sample size:

干预措施:

2μg/kg/min的速度持续泵注甲氧明,液体治疗方案同C组

干预措施代码:

Intervention:

2 ug/kg/min continuous infusion of methoxymine at the same rate as group C.

Intervention code:

组别:

目标导向液体治疗组

样本量:

20

Group:

Group G

Sample size:

干预措施:

根据SV、SVV、MAP、CI指导补液

干预措施代码: