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布托啡诺在胃肠镜麻醉中的ED95与等效舒芬太尼的副作用比较
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注册号:

Registration number:

ChiCTR1900022780 

最近更新日期:

Date of Last Refreshed on:

2019-04-28 

注册时间:

Date of Registration:

2019-04-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

布托啡诺在胃肠镜麻醉中的ED95与等效舒芬太尼的副作用比较 

Public title:

Side effects of Ed95 butorphanol in gastroenteroscopic anesthesia compared with equivalent sufentanil: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

布托啡诺在胃肠镜麻醉中的ED95与等效舒芬太尼的副作用比较 

Scientific title:

Side effects of Ed95 butorphanol in gastroenteroscopic anesthesia compared with equivalent sufentanil: a 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:

朱晓娜 

研究负责人:

徐旭仲 

Applicant:

Xiaona Zhu 

Study leader:

Xuzhong Xu 

申请注册联系人电话:

Applicant telephone:

+86 15858805267 

研究负责人电话:

Study leader's telephone:

+86 13706657799 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 010 950507-757076  

申请注册联系人电子邮件:

Applicant E-mail:

249323891@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xuzhong@263.net 

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:

浙江省温州市瓯海区南白象街道上蔡村 

研究负责人通讯地址:

浙江省温州市瓯海区南白象街道上蔡村 

Applicant address:

Shangcai Villiage, Nanbaixiang Street, Ouhai District, Wenzhou, Zhejiang, China  

Study leader's address:

Shangcai Villiage, Nanbaixiang Street, Ouhai District, Wenzhou, Zhejiang, China  

申请注册联系人邮政编码:

Applicant postcode:

325000 

研究负责人邮政编码:

Study leader's postcode:

325000 

申请人所在单位:

温州医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Wenzhou 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:

2019-013 

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:

温州医科大学附属第一医院伦理委员会 

Name of the ethic committee:

The Independent Ethics Committee at the First Affiliated Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-28 

伦理委员会联系人:

金嵘 

Contact Name of the ethic committee:

Rong jin 

伦理委员会联系地址:

浙江省温州市瓯海区南白象街道上蔡村 

Contact Address of the ethic committee:

Shangcai Villiage, Nanbaixiang Street, Ouhai District, Wenzhou, Zhejiang, 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:

温州医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Wenzhou Medical University  

研究实施负责(组长)单位地址:

浙江省温州市瓯海区南白象街道上蔡村 

Primary sponsor's address:

Shangcai Villiage, Nanbaixiang Street, Ouhai District, Wenzhou, Zhejiang  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

温州市

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属第一医院

具体地址:

瓯海区南白象街道上蔡村

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University

Address:

Shangcai Villiage, Nanbaixiang Street, Ouhai District

经费或物资来源:

自筹资金 

Source(s) of funding:

self-financing 

研究疾病:

无痛胃肠镜麻醉 

Target disease:

gastroenteroscopic anesthesia 

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:

探究布托啡诺在无痛胃肠镜术中的最佳剂量及确定其可行性,以及与等效舒芬太尼对比应用于无痛胃肠镜检查,观察术后乏力、腹痛、头晕等并发症的发生率,观察丙泊酚用量和离室时间,比较两者的优劣。 

Objectives of Study:

To explore the optimal dose of butophanol in painless gastroenteroscopy and determine its feasibility, and to compare it with the equivalent sufentanil in painless gastroenteroscopy, observe the incidence of postoperative complications such as fatigue, abdominal pain, dizziness, and observe the dosage of propofol and the time to leave the postoperative room. 

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. 门诊无痛胃肠镜患者; 2. 18周岁及以上65周岁以下; 3. BMI 18.5-30kg/m2; 4. ASA 分级Ⅰ到Ⅲ级; 5. 预计医生胃肠镜操作时间<30分钟。 

Inclusion criteria

1. Outpatient of painless gastroenteroscopy; 2. Aged 18 to 65 years; 3. BMI 18.5-30kg/m2; 4. ASA classification from I to III grade; 5. The expecte time of gastroenteroscopy operation is less than 30 minutes. 

排除标准:

1. 排除心率<50次/分,收缩压<90mmHg或者>180mmHg; 2. 排除急性上呼吸道感染; 3. 滥用镇痛药物史或半个月内使用过镇痛药,排除甲状腺术后、服用甲状腺素药物患者,排除术前乏力,低钾,重症肌无力患者,排除有相关药物过敏者,消化道肿瘤患者,凝血功能异常患者,肝肾功能损伤患者以及语言、意识障碍不能配合者。 

Exclusion criteria:

1. Exclude heart rate < 50 beats/min, systolic blood pressure < 90mmHg or > 180mmHg; 2. Exclude acute upper respiratory tract infection; 3. Exclude patients with history of analgesic abuse or analgesic drugs used within half a month. Patients who got thyroid surgery or taking thyroxine drugs were excluded. preoperative weakness, hypokalemia, and myasthenia gravis, relevant drug allergy, gastrointestinal tumors, coagulation abnormalities, hepatic and renal dysfunction, difficult to communicate and cannot cooperate was also excluded. 

研究实施时间:

Study execute time:

From2019-05-01To 2019-07-01 

征募观察对象时间:

Recruiting time:

From2019-05-01To 2019-05-20 

干预措施:

Interventions:

组别:

布托啡诺组

样本量:

100

Group:

Group 1

Sample size:

干预措施:

应用布托啡诺镇痛

干预措施代码:

Intervention:

apply butorphanol for analgesia

Intervention code:

组别:

舒芬太尼组

样本量:

100

Group:

Group 2

Sample size:

干预措施:

应用舒芬太尼镇痛

干预措施代码:

Intervention:

apply sufentanil for analgesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

布托啡诺的ED95

指标类型:

主要指标 

Outcome:

ED95 of butorphanol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乏力的发生率

指标类型:

主要指标 

Outcome:

the incidence of fatigue

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

离室时间

指标类型:

次要指标 

Outcome:

time in postoperative room

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙泊酚用量

指标类型:

次要指标 

Outcome:

dosage of propofol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NRS评分

指标类型:

次要指标 

Outcome:

NRS score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头晕发生率

指标类型:

次要指标 

Outcome:

incidence of dizziness

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):

由麻醉医师应用随机数字表法行随机化。

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

Andomization was performed by the anesthetist using the random number table method

盲法:

同一位麻醉医师抽药并贴好阶梯标签,另一位麻醉医师进行术中麻醉操作,第三位麻醉医师负责术后收集资料和记录。

Blinding:

One anesthetist is responsible for taking the medicine and labeling it. Another anesthetist performs anesthetic operation. The third anesthetist is responsible for collecting datas and taking a record.

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):

原始数据将于试验结束后上传至本网站对外公开

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

The data will be uploaded to this website and accessible to pubic after trial

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:

温州医科大学附属第一医院

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

The First Affiliated Hospital of Wenzhou Medical University

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:

 2019-04-25
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