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两种麻醉深度对腹腔镜结直肠手术后胃肠功能障碍发生率的影响:单中心前瞻性随机临床试验
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注册号:

Registration number:

ChiCTR1800018725 

最近更新日期:

Date of Last Refreshed on:

2020-12-07 

注册时间:

Date of Registration:

2018-10-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

两种麻醉深度对腹腔镜结直肠手术后胃肠功能障碍发生率的影响:单中心前瞻性随机临床试验 

Public title:

Effect of Two Levels of Anaesthetic Depth on Postoperative Gastrointestinal Dysfunction after Laparoscopic Colorectal Surgery: A Single-center Prospective Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

两种麻醉深度对腹腔镜结直肠手术后胃肠功能障碍发生率的影响:单中心前瞻性随机临床试验 

Scientific title:

Effect of Two Levels of Anaesthetic Depth on Postoperative Gastrointestinal Dysfunction after Laparoscopic Colorectal Surgery: A Single-center Prospective Randomized Controlled 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:

刘卫锋 

研究负责人:

刘克玄 

Applicant:

Weifeng Liu 

Study leader:

Kexuan Liu 

申请注册联系人电话:

Applicant telephone:

+86 13826003364 

研究负责人电话:

Study leader's telephone:

+86 13710684096 

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:

sglwfeng01@21cn.com 

研究负责人电子邮件:

Study leader's E-mail:

liukexuan705@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:

中国广东省广州市白云区广州大道北1838号 

研究负责人通讯地址:

中国广东省广州市白云区广州大道北1838号 

Applicant address:

1838 North Guangzhou Road, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

1838 North Guangzhou Road, Baiyun District, Guangzhou, Guangdong, 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:

南方医科大学南方医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Nanfang Hospital, Southern 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:

NFEC-2018-107 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Nanfang Hospital, Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-17 

伦理委员会联系人:

胡兴媛 

Contact Name of the ethic committee:

Xingyuan Hu 

伦理委员会联系地址:

中国广东省广州市白云区广州大道北1838号南方医科大学南方医院伦理委员会 

Contact Address of the ethic committee:

1838 North Guangzhou Road, Baiyun District, Guangzhou, Guangdong, 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:

南方医科大学南方医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Nanfang Hospital, Southern Medical University 

研究实施负责(组长)单位地址:

中国广东省广州市白云区广州大道北1838号 

Primary sponsor's address:

1838 North Guangzhou Road, Baiyun District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

南方医科大学南方医院院级项目 

Source(s) of funding:

Hospital-level Project of Nanfang Hospital, Southern Medical University 

研究疾病:

结直肠癌 

Target disease:

Colorectal Carcinoma 

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:

观察不同麻醉深度对全麻腹腔镜结直肠手术后胃肠功能障碍发生率的影响。 

Objectives of Study:

To investigate the effect of different anaesthetic depths on postoperative gastrointestinal dysfunction after laparoscopic colorectal 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:

行择期腹腔镜结直肠手术的成年(18岁及以上)、ASA I-III级、同意参加本研究的患者。 

Inclusion criteria

Selected laparoscopic colorectal surgery; aged >= 18 years old; ASA I-III; agree to participate in this study and sign the informed consent form. 

排除标准:

患者年龄小于18岁;急诊手术;不能阅读、理解与交流;既往接受过食管或腹部手术;术前存在肠梗阻;ASA IV级或以上;长期使用阿片类药物、非甾体抗炎药或类固醇激素。 

Exclusion criteria:

Aged < 18 years; emergent surgery; illiterate or communication disability; esophageal or abdominal surgery history; before surgery; ASA IV-V; long-term exposure of opioids, NSAIDs or steroids. 

研究实施时间:

Study execute time:

From2018-10-08To 2021-09-01 

征募观察对象时间:

Recruiting time:

From2018-10-08To 2021-09-01 

干预措施:

Interventions:

组别:

浅麻醉组

样本量:

427

Group:

Light Anaesthetic Depth Group

Sample size:

干预措施:

术中全麻深度维持目标BIS值为50

干预措施代码:

Intervention:

General anaesthesia with intraoperative BIS targeted at 50

Intervention code:

组别:

深麻醉组

样本量:

427

Group:

Deep Anaesthetic Depth Group

Sample size:

干预措施:

术中全麻深度维持目标BIS值为35

干预措施代码:

Intervention:

General anaesthesia with intraoperative BIS targeted at 35

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三级甲等医院 

Institution
hospital:

Nanfang Hospital, Southern Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后胃肠功能障碍的发生率

指标类型:

主要指标 

Outcome:

Prevalence of postoperative gastrointestinal dysfunction during hospital stay

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后恢复质量评分

指标类型:

次要指标 

Outcome:

Post-op Quality of Recovery

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后6小时血清I-FABP水平

指标类型:

次要指标 

Outcome:

Serous I-FABP at 6 h post-op

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天并发症

指标类型:

次要指标 

Outcome:

Complications at 30d

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非计划再入院率

指标类型:

次要指标 

Outcome:

Incidence of unplanned readmission

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 65 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):

由统计学专家使用统计软件包产生两套各854个随机号。

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

Random sequences will be generated by statistician through computer software.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是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 http://www.chictr.org.cn/

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

Chinese clinical trial registry http://www.chictr.org.cn/

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:

CRF表收集数据,EDC管理数据。

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

Data will be collected with CRFs and managed with EDC.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-06
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