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腹直肌鞘或腹横肌平面神经阻滞联合右美托咪定在胃肠外科手术麻醉中的应用
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注册号:

Registration number:

ChiCTR1800014437 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

腹直肌鞘或腹横肌平面神经阻滞联合右美托咪定在胃肠外科手术麻醉中的应用  

Public title:

Rectus sheath or transversus abdominis plane nerve block and intravenous infusion of dexmedetomidine in patients undergoing gastrointestinal surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

腹直肌鞘或腹横肌平面神经阻滞联合右美托咪定在胃肠外科手术麻醉中的应用  

Scientific title:

Rectus sheath or transversus abdominis plane nerve block and intravenous infusion of dexmedetomidine in patients undergoing gastrointestinal 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:

李永华 

研究负责人:

李永华 

Applicant:

Yonghua Li 

Study leader:

Yonghua Li 

申请注册联系人电话:

Applicant telephone:

+86 13795439726 

研究负责人电话:

Study leader's telephone:

+86 13795439726 

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:

liyonghua1207@126.com 

研究负责人电子邮件:

Study leader's E-mail:

liyonghua1207@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:

上海市凤阳路415号 

研究负责人通讯地址:

上海市凤阳路415号 

Applicant address:

415 Fengyang Road, Shanghai, China 

Study leader's address:

415 Fengyang Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200003 

研究负责人邮政编码:

Study leader's postcode:

200003 

申请人所在单位:

上海长征医院 

Applicant's institution:

Shanghai Changzheng 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:

ChiECRCT-20170107 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

Chinese Ethics Committee of Registering Clinical Trials  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-11 

伦理委员会联系人:

吴泰相 

Contact Name of the ethic committee:

Taixiang Wu 

伦理委员会联系地址:

中国注册临床试验伦理审查委员会 

Contact Address of the ethic committee:

Chinese Ethics Committee of Registering Clinical Trials  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 18980604562 

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:

上海长征医院 

Primary sponsor:

Shanghai Changzheng Hospital 

研究实施负责(组长)单位地址:

上海市凤阳路415号 

Primary sponsor's address:

415 Fengyang Road, 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(区县):

Country:

Chian

Province:

Shanghai

City:

单位(医院):

上海长征医院

具体地址:

上海市凤阳路415号

Institution
hospital:

Shanghai Changzheng Hospital

Address:

415 Fengyang Road, Shanghai

经费或物资来源:

自筹 

Source(s) of funding:

self-finance 

研究疾病:

胃肠外科开腹手术的麻醉 

Target disease:

anesthesia for gastrointestinal 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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

观察腹直肌鞘或腹横肌平面神经阻滞联合静脉输注右美托咪定对于改善在胃肠外科手术麻醉质量的有效性和可行性  

Objectives of Study:

To discuss the feasibility and validity of Rectus sheath or transversus abdominis plane nerve block and intravenous infusion of dexmedetomidine in patients undergoing gastrointestinal surgery 

药物成份或治疗方案详述:

腹直肌鞘或腹横肌平面神经阻滞;静脉输注右美托咪定 

Description for medicine or protocol of treatment in detail:

Rectus sheath or transversus abdominis plane nerve block;intravenous infusion of dexmedetomidine 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

年龄在20-80岁,ASA分级在I-Ⅲ级,拟行胃肠道手术的患者。 

Inclusion criteria

Aged 20-80 years old, ASA I-III, patients scheduled for gastrointestinal surgery. 

排除标准:

1.有重要脏器功能不全者。 2.存在精神心理问题者。 3.存在严重窦缓或II度II型传导阻滞的患者。 

Exclusion criteria:

1. patients with important organ dysfunction; 2. patients with psychosocial problems; 3. patients with severe sinus bradycardia or II degree II conduction block. 

研究实施时间:

Study execute time:

From2018-01-15To 2018-09-30 

干预措施:

Interventions:

组别:

试验1组

样本量:

50

Group:

1

Sample size:

干预措施:

腹直肌鞘或腹横肌平面神经阻滞

干预措施代码:

Intervention:

Rectus sheath or transversus abdominis plane nerve block

Intervention code:

组别:

试验2组

样本量:

50

Group:

2

Sample size:

干预措施:

静脉输注右美托咪定

干预措施代码:

Intervention:

intravenous infusion of dexmedetomidine

Intervention code:

组别:

试验3组

样本量:

50

Group:

3

Sample size:

干预措施:

神经阻滞和静脉右美托咪定

干预措施代码:

Intervention:

Rectus sheath or transversus abdominis plane nerve block and intravenous infusion of dexmedetomidine

Intervention code:

组别:

对照组

样本量:

50

Group:

4

Sample size:

干预措施:

静脉舒芬太尼

干预措施代码:

Intervention:

infusion of sufentanil

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(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长征医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Changzheng Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

收缩压

指标类型:

主要指标 

Outcome:

SBP

Type:

Primary indicator 

测量时间点:

入室时、切皮前、切皮后1min、切皮后2min、切皮后3min、切开腹膜时、腹腔探查5min、腹腔探查10min、腹腔探查15min时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

主要指标 

Outcome:

HR

Type:

Primary indicator 

测量时间点:

入室时、切皮前、切皮后1min、切皮后2min、切皮后3min、切开腹膜时、腹腔探查5min、腹腔探查10min、腹腔探查15min时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛模拟量表评分

指标类型:

主要指标 

Outcome:

VAS pain score

Type:

Primary indicator 

测量时间点:

PACU、术后2h、6h、12h、24h、48h的疼痛VAS评分

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

羟考酮用药剂量

指标类型:

主要指标 

Outcome:

dose of oxycodone

Type:

Primary indicator 

测量时间点:

术后12小时、24小时、48小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

舒芬太尼用量

指标类型:

次要指标 

Outcome:

dose of sufentanil

Type:

Secondary indicator 

测量时间点:

手术结束时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

苏醒时间

指标类型:

次要指标 

Outcome:

awake time

Type:

Secondary indicator 

测量时间点:

患者苏醒时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

拔管时间

指标类型:

次要指标 

Outcome:

extubation time

Type:

Secondary indicator 

测量时间点:

拔管时间

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后恶心呕吐

指标类型:

次要指标 

Outcome:

PONV

Type:

Secondary indicator 

测量时间点:

清醒拔管时、术后第2小时、第24小时、第48小时

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 20 years
最大 Max age 80 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):

统计教研室副教授用统计学软件产生随机序列

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

The random sequences will be produced with statistical software by an associate professor of the Department of statistical teaching and research.

盲法:

因为涉及神经阻滞这一有创操作,基于患者利益,不设盲法。

Blinding:

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):

上传试验完成后的统计结果

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

upload the stastic results

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:

 2018-01-13
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