Today is 2019-06-19

Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on Quality of Postoperative Analgesia and Recovery of Bowel Movements in Normal-weight or Overweight Patients Who are Middle-aged or Aged Undergoing Laparoscopic Nephrectomy.
download

注册号:

Registration number:

ChiCTR-IPR-15007628 

最近更新日期:

Date of Last Refreshed on:

2015-12-23 

注册时间:

Date of Registration:

2015-12-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同浓度右美托咪定对腹腔镜肾切除手术的正常体重或超重的中老年病人术后镇痛及肠功能恢复的影响研究 

Public title:

Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on Quality of Postoperative Analgesia and Recovery of Bowel Movements in Normal-weight or Overweight Patients Who are Middle-aged or Aged Undergoing Laparoscopic Nephrectomy. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同浓度右美托咪定对腹腔镜肾切除手术的正常体重或超重的中老年病人术后镇痛及肠功能恢复的影响研究 

Scientific title:

Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on Quality of Postoperative Analgesia and Recovery of Bowel Movements in Patients Undergoing Laparoscopic Nephrectomy. 

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:

齐峰 

研究负责人:

齐峰 

Applicant:

Feng QI 

Study leader:

Feng QI 

申请注册联系人电话:

Applicant telephone:

+86 18560083756 

研究负责人电话:

Study leader's telephone:

+86 18560083756 

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:

qifeng66321@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

qifeng66321@sina.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:

山东省济南市文化西路107号 

研究负责人通讯地址:

山东省济南市文化西路107号 

Applicant address:

107 Wenhuaxi Road, Jinan, Shandong 

Study leader's address:

107 Wenhuaxi Road, Jinan, Shandong 

申请注册联系人邮政编码:

Applicant postcode:

250012 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

山东大学齐鲁医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Qilu Hospital of Shandong 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:

(科)伦审第(2015066)号 

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:

山东大学齐鲁医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Qilu Hospital of Shandong University 

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:

 

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:

山东大学齐鲁医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Qilu Hospital of Shandong University 

研究实施负责(组长)单位地址:

山东省济南市文化西路107号 

Primary sponsor's address:

107 Wenhuaxi Road, Jinan, Shandong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东大学齐鲁医院

具体地址:

山东省济南市文化西路107号

Institution
hospital:

Qilu Hospital of Shandong University

Address:

107 Wenhuaxi Road, Jinan, Shandong

经费或物资来源:

中国国家自然科学基金 

Source(s) of funding:

Natural Science Foundation of China 

研究疾病:

术后镇痛及肠功能障碍 

Target disease:

Postoperative Analgesia and Recovery of Bowel Movements 

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:

上市后药物 

Study phase:

研究目的:

研究右美托咪定复合舒芬太尼对患者术后镇痛及肠功能恢复的影响 

Objectives of Study:

Study the impact of Dexmedetomidine combined with sufentanil on Quality of Postoperative Analgesia and Recovery of Bowel Movements  

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:

ASA I ~ II级;年龄30-80岁;择期行腹腔镜肾部分/根治性切除术  

Inclusion criteria

Patients who are prepared to undergo laparoscopic nephrectomy in Qilu Hospital of Shandong University are enrolled in this study if they met the following inclusion criteria: aged between 30 and 80 years, American Society of Anesthesiologists grade I or II.  

排除标准:

严重心肺、肝功能不全,甲亢;术前使用血管活性药物或镇静催眠药物(>3个月);已知对试验相关药物过敏;  

Exclusion criteria:

severe heart, lung, liver diseases or hyperthyroidism; use of vasoactive or sedative-hypnotic drugs before surgery(>3 months); be allergic to test drugs.  

研究实施时间:

Study execute time:

From2015-12-28To  

干预措施:

Interventions:

组别:

O

样本量:

30

Group:

O

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

normal saline

Intervention code:

组别:

D1

样本量:

30

Group:

D1

Sample size:

干预措施:

低剂量右美托咪定

干预措施代码:

Intervention:

low-dose dexmedetomidine

Intervention code:

组别:

D2

样本量:

30

Group:

D2

Sample size:

干预措施:

高剂量右美托咪定

干预措施代码:

Intervention:

high-dose dexmedetomidine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学齐鲁医院 

单位级别:

三级甲等 

Institution
hospital:

Qilu Hospital of Shandong University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后疼痛分级

指标类型:

主要指标 

Outcome:

level of postoperative pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排气时间

指标类型:

主要指标 

Outcome:

time of flatus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便时间

指标类型:

主要指标 

Outcome:

time of defecation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征

指标类型:

次要指标 

Outcome:

vital sign

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

次要指标 

Outcome:

adverse reaction

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:

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 30 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):

计算机随机数字表

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

computer-generated randomization table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-12-23
return list