Today is 2022-01-23

Hydromorphone hydrochloride combined with butorphanol for postoperative analgesia after video-assisted thoracoscopic surgery
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注册号:

Registration number:

ChiCTR2200055649 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

盐酸氢吗啡酮联合布托啡诺用于胸腔镜手术术后镇痛的观察 

Public title:

Hydromorphone hydrochloride combined with butorphanol for postoperative analgesia after video-assisted thoracoscopic surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

盐酸氢吗啡酮联合布托啡诺用于胸腔镜手术术后镇痛的观察:一项临床探索性研究 

Scientific title:

Hydromorphone hydrochloride combined with butorphanol for postoperative analgesia after video-assisted thoracoscopic surgery: an exploratory clinical 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:

姚婧鑫 

研究负责人:

景龙年 

Applicant:

Yao, Jingxin 

Study leader:

Jing, Longnian 

申请注册联系人电话:

Applicant telephone:

18800161300 

研究负责人电话:

Study leader's telephone:

13146556349 

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:

456789op@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13146556349@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:

北京市丰台区南四环西路119号 

研究负责人通讯地址:

北京市丰台区南四环西路119号 

Applicant address:

No. 119# South Nansihuan Road, Fengtai District, Beijing, China 

Study leader's address:

No. 119# South Nansihuan Road, Fengtai District, Beijing, 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:

首都医科大学附属北京天坛医院 

Applicant's institution:

Beijing Tiantan Hospital, Capital 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:

ChiECRCT20210554 

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:

2021-12-20 

伦理委员会联系人:

吴莼 

Contact Name of the ethic committee:

Wu Chun 

伦理委员会联系地址:

中国香港特别行政区九龙浸会大学道中国临床试验注册中心香港中心 

Contact Address of the ethic committee:

Chinese Clinical trial Hong Kong Centre, Baptist University Road, Kowloon Tong, Hong Kong SAR, 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:

chictr001@chictr.org.cn 

研究实施负责(组长)单位:

首都医科大学附属北京天坛医院 

Primary sponsor:

Beijing Tiantan Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

首都医科大学附属北京天坛医院 

Primary sponsor's address:

Beijing Tiantan Hospital, Capital Medical University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京天坛医院

具体地址:

北京市丰台区南四环西路119号

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University

Address:

No. 119# South Nansihuan Road, Fengtai District, Beijing, China

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

术后疼痛 

Target disease:

postoperative pain 

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:

改善胸腔镜手术术后镇痛的镇痛效果和加少并发症。 

Objectives of Study:

To improve the analgesic effect and reduce complications after thoracoscopic 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:

择期经胸腔镜行肺叶/肺楔形切除术患者 (1)年龄18-65周岁; (2)ASAⅠ或Ⅱ级; (3)签署知情同意书。 

Inclusion criteria

Patients underwent elective thoracoscopic wedge resection of the lung/lobe. (1)Aged 18-65; (2) ASA ⅰ or ⅱ; (3) Signed informed consent. 

排除标准:

(1)既往有阿片类药物过敏史 ; (2)既往有全麻术后恶心呕吐史以及异常麻醉恢复史; (3)术前肝、肾功能异常(谷丙转氨酶、谷草转氨酶、肌酐、尿素氮超过正常值两倍); (4)无法与人正常沟通,不能理解VAS评分,不会使用镇痛泵者(VAS评分≥3时按压); (5)术前24h内使用镇静药、止吐药、抗瘙痒药物; (6)因慢性疼痛或精神、神经系统疾病长期使用镇痛药或抗精神失常药物 (包括阿片类药物、非甾体抗炎类药物、镇静药、抗抑郁药等); (7)严重心肺功能障碍。 

Exclusion criteria:

(1) History of opioid allergy; (2) History of nausea and vomiting after general anesthesia and recovery from abnormal anesthesia; (3) Liver and/or renal dysfunction before surgery (alanine aminotransferase, aspartate aminotransferase, creatinine and urea nitrogen more than twice the normal value); (4) Unable to communicate with others, unable to complete VAS score, and unable to use analgesia pump (press when VAS score ≥3); (5) Sedative drugs, antiemetic drugs and antipruritus drugs were used within 24 hours before surgery; (6) Long-term use of analgesics or antipsychotic drugs (including opioids, non-steroidal anti-inflammatory drugs, sedatives, antidepressants, etc.) for chronic pain or mental or nervous system diseases; (7) Severe cardiopulmonary dysfunction. 

研究实施时间:

Study execute time:

From2022-01-15To 2023-01-15 

征募观察对象时间:

Recruiting time:

From2022-01-15To 2022-01-15 

干预措施:

Interventions:

组别:

HB

样本量:

30

Group:

HB

Sample size:

干预措施:

氢吗啡酮联合布托菲诺

干预措施代码:

Intervention:

Hydromorphone hydrochloride combined with butorphanol

Intervention code:

组别:

H

样本量:

30

Group:

H

Sample size:

干预措施:

氢吗啡酮

干预措施代码:

Intervention:

Hydromorphone hydrochloride

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京天坛医院 

单位级别:

三级 

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University  

Level of the institution:

Tertiary hospitals 

测量指标:

Outcomes:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS score

Type:

Primary indicator 

测量时间点:

术后第6,12,24,48小时

测量方法:

VAS评分量表

Measure time point of outcome:

Measure method:

指标中文名:

RASS评分

指标类型:

主要指标 

Outcome:

RSAA score

Type:

Primary indicator 

测量时间点:

术后6,12,24,48小时

测量方法:

RASS评分量表

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

Not stated

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

Not stated

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-15
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