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静脉自控镇痛(PCIA)联合氟比洛芬酯、地佐辛用于肺叶切除术后镇痛的前瞻性随机对照临床研究
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注册号:

Registration number:

ChiCTR1800018563 

最近更新日期:

Date of Last Refreshed on:

2018-09-25 

注册时间:

Date of Registration:

2018-09-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

静脉自控镇痛(PCIA)联合氟比洛芬酯、地佐辛用于肺叶切除术后镇痛的前瞻性随机对照临床研究 

Public title:

A prospective, randomized controlled clinical trial: comparison of the analgesia effects between patient-control intravenous analgesia (PCIA) combinations of flurbiprofen with dezocine based on patient-control intravenous analgesia (PCIA) following lobectomy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

静脉自控镇痛(PCIA)联合氟比洛芬酯、地佐辛 用于肺叶切除术后镇痛的前瞻性随机对照临床研究 

Scientific title:

A prospective, randomized controlled clinical trial: comparison of the analgesia effects between patient-control intravenous analgesia (PCIA) combinations of flurbiprofen with dezocine based on patient-control intravenous analgesia (PCIA) following lobectomy 

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:

周健 

研究负责人:

刘伦旭 

Applicant:

Jian Zhou 

Study leader:

Lunxu Liu 

申请注册联系人电话:

Applicant telephone:

+86 18982116778 

研究负责人电话:

Study leader's telephone:

+86 18980601525 

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:

jianzhouscu@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

lunxu_liu@aliyun.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:

四川省成都市华西医院胸外科 

研究负责人通讯地址:

四川省成都市华西医院胸外科 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2018-289 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川大学华西医院生物医学伦理委员会 

Name of the ethic committee:

The Institutional Ethic Committee for Clinical Research of West China Hospital, SiChuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-24 

伦理委员会联系人:

梁茂植 

Contact Name of the ethic committee:

Maozhi Liang 

伦理委员会联系地址:

四川大学华西医院 

Contact Address of the ethic committee:

West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市华西医院胸外科 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市华西医院胸外科

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

刘伦旭教授SCI论文基金 

Source(s) of funding:

SCI funding to o Dr. Lunxu Liu 

研究疾病:

肺部疾病 

Target disease:

pulmonary disease 

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:

探究在静脉自控镇痛(PCIA)的基础上,联合氟比洛芬酯、地佐辛用于肺叶切除手术患者术后镇痛的最佳组合和最少不良反应,也即镇痛效果最好、不良反应最少。 

Objectives of Study:

The objective of this study is to explore the best postoperative analgesic regimen with the least adverse effects of dezocine, flurbiprofen axetil, and their combinations. 

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. 18岁≤年龄≤70岁; 2. 男性体重≥45kg,女性体重≥42kg; 3. 手术方式为肺叶切除; 4. ASA评分I-II级; 5. 能理解数字分级疼痛评分(NRS)法; 6. 能理解静脉自控镇痛(PCIA)的使用方法; 7. 所患疾病、术前用药情况等资料完整; 8. 自愿参加本研究并签署知情同意书。 

Inclusion criteria

1. Patients aged 18 to 70 years; 2. Male: weight ≥45kg, female: weight ≥42kg; 3. Patients undergoing pulmonary lobectomy surgery; 4. ASA scores I-II grade; 5. Known numeric rating scales (NRS); 6. Known how to use patient-controlled intravenous analgesia (PCIA); 7. Had essential complete materials such as clinical staging of lung cancer and medications situation; 8. Willing to participant after reading and signing an informed consent form. 

排除标准:

1. 戒烟时间<2周; 2. 有药物滥用史、酗酒史; 3. 对阿片类、非甾体类抗炎药物(NSAIDs)过敏; 4. 妊娠或哺乳期妇女; 5. 患有严重精神疾病; 6. 有胃肠道系统或血液系统基础疾病; 7. 有心肌缺血病史; 8. III级高血压患者; 9. 术前接受过放疗或新辅助化疗; 10. 经研究者判断患者不适宜纳入试验。 

Exclusion criteria:

1. Time for smoking cessation <2 weeks; 2. Patients undergoing other pulmonary operations rather than lobectomy; 3. Patient with allergies to opioids, non-steroidal anti-inflammatory drugs (NSAIDs); 4. Patients were pregnant or breastfeeding women; 5. Patients with preoperative severe mental illness; 6. Patients with preoperative gastrointestinal or blood system disease; 7. Patients with grade 3 hypertension; 8. Patients underwent cardiac ischemia; 9. Patients received preoperative radiotherapy or neoadjuvant chemotherapy; 10. The investigator judges that the patient is not suitable for inclusion in the trial. 

研究实施时间:

Study execute time:

From2018-11-01To 2019-10-30 

征募观察对象时间:

Recruiting time:

From2018-11-01To 2019-04-30 

干预措施:

Interventions:

组别:

A组

样本量:

58

Group:

Group A

Sample size:

干预措施:

PCIA+氟比洛芬酯 50mg

干预措施代码:

Intervention:

PCIA + Flurbiprofen axetil 50mg

Intervention code:

组别:

B组

样本量:

58

Group:

Group B

Sample size:

干预措施:

PCIA+地佐辛 5mg

干预措施代码:

Intervention:

PCIA+ dezocine 5mg

Intervention code:

组别:

C组

样本量:

58

Group:

Group C

Sample size:

干预措施:

PCIA+氟比洛芬酯 50mg+地佐辛 5mg

干预措施代码:

Intervention:

PCIA + flurbiprofen axetil 50mg+ dezocine 5mg

Intervention code:

组别:

D组

样本量:

58

Group:

Group D

Sample size:

干预措施:

PCIA+氟比洛芬酯(半量)+地佐辛(半量)

干预措施代码:

Intervention:

PCIA + flurbiprofen axetil 25mg+ dezocine 2.5mg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

数字分级疼痛评分(NRS)

指标类型:

主要指标 

Outcome:

The numeric rating scales (NRS)

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PCIA中舒芬太尼使用总量

指标类型:

主要指标 

Outcome:

the total consumption of sufentanil after operations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应:恶心、呕吐、头晕、乏力、嗜睡、瘙痒、腹胀、便秘、欣快感、呼吸抑制、消化不良

指标类型:

主要指标 

Outcome:

incidence of experimental drug-related adverse effects: nausea, vomiting, dizziness, fatigue, drowsiness, pruritus, abdominal distention, bloating, constipation, euphoria, respiratory depression and indigestion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后镇痛费用

指标类型:

次要指标 

Outcome:

the analgesia cost

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后置管时间

指标类型:

次要指标 

Outcome:

chest tube duration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院时长

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:

胃肠排气时间

指标类型:

次要指标 

Outcome:

gastrointestinal exhaust time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆中IL-1β、IL-6、IL-8、IL-2、TNF-α、CRP、PGE2、5-HT水平

指标类型:

次要指标 

Outcome:

the serum level of interleukin-1β (IL-1β), IL-6, IL-8, IL-2, tumor necrosis factor-α (TNF-α), C-reactive protein (CRP)、prostaglandin E2 (PGE2)、5-hydroxytryptamine (5-HT)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

地佐辛追加时间、次数及追加量

指标类型:

次要指标 

Outcome:

dezocine additional time,times,additional quantity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后下床时间

指标类型:

次要指标 

Outcome:

postoperative time to get out of bed

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

本研究采用完全随机方法进行随机化分组,由项目负责人使用计算机产生的随机数字法产生随机序列,项目负责人确定病例的入组,同时通知该病例所在医疗组。项目研究助理应及时接收入组通知,并严格按照分组确定受试者进入各研究组。

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

We will perform the randomization to assign candidates into 5 groups based on the computer-generated random numbers. When receiving a patient who meets the inclusion criteria, the doctors will assign the newly participant to a group regarding the number on the envelopes.

盲法:

本研究采用单盲。参与者静脉输注的药物均为统一包装,无法看出差别,分组情况不会泄露。药物静脉输注的实施由专门的护士负责,其知情可以保证药物的正确输注。数字分级疼痛评分(NRS)由专门的科研人员负责。结果评价者可了解分组情况,进而来控制和安排全部试验,以及对意外及时处理。

Blinding:

All the drugs will be packed with the same outlook. The assignment will be blinded to all the participants. However, the nurse will be aware of the study group to guarantee safe drugs intravenous infusion. The outcome assessors will be responsible for assessing and recording patients characteristic after treatment, and will know the study group in case of emergency.

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):

2020.3.1 通过此平台和发表文章公示

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

March 1, 2020. To share our results through this platform and published paper.

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:

1. 研究者根据受试者的原始观察记录,将数据及时、完整、正确、清晰地载入病例报告表。该试验的监查员应监查试验的进行是否遵循试验方案,确认病例报告表填写正确完整,并与原始资料一致。如有错误和遗漏,及时要求研究者改正。修改时需保持原有记录清晰可见,改正处需经研究者签名并注明日期。 2. 经过监查员检查后的病例报告表,有监查员核查签字后,及时送交临床试验数据管理员。对于完成的病例报告表在研究者、监查员、数据管理员之间的传送应有专门的记录,收到时应有相应的签名,记录需妥善保存。 3. 数据管理员在数据录入前再次核查,发现问题及时通知监查员,要求研究者做出回答。他们之间的各种疑问及解答的交换应当采用疑问表形式,疑问表应保存备查。 4. 数据录入员数据采用二次录入。录入过程反省问题或意外情况,应做好登记并及时报告,以便迅速处理问题,数据录入结束后应抽查部分观察表格,了解录入质量,分析并处理存在的问题。 5. 原始病历报告表在按要求完成数据录入和核查后,按编号的顺序归档保存,并填写检索目录等,以备考查。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,应分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏,所有原始档案应按规定期限保存。

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

All the recruited patients’ demographic and clinical data will be recorded by independent investigators. Preoperative data will be recorded within 3 days after recruitment. Operative data will be recorded within 2 days after surgery. Postoperative data record will be finished within 3 days after discharge. For patients discharge home, we will retrieve information by telephone follow-up, and these data record will be finished within 3 days after follow up. We have a data management safety committee (DMSC) comprised of 5 independent investigators. They will supervise the study protocol adherence, confirm that the CRF is correctly completed and consistent with the original data. If there are any errors or omissions, they will ask the investigator to correct them in time. The original record will be kept clearly visible when revising, and it will be signed by the investigator and dated where there are modifications. All the data can be only obtained by the study researcher who have signed the confidential disclosure agreement. Data without patients’ private information will be published after the study. The adherence to the study protocol, data collection, statistical analysis as well as related safe issues will be strictly monitored by the Institutional Ethic Committee of West China Hospital, SiChuan University. All the recruited patients’ demographic and clinical data will be recorded by independent investigators. Preoperative data will be recorded within 3 days after recruitment. Operative data will be recorded within 2 days after surgery. Postoperative data record will be finished within 3 days after discharge. For patients discharge home, we will retrieve information by telephone follow-up, and these data record will be finished within 3 days after follow up. We have a data management safety committee (DMSC) comprised of 5 independent investigators. They will supervise the study protocol adherence, confirm that the CRF is correctly completed and consistent with the original data. If there are any errors or omissions, they will ask the investigator to correct them in time. The original record will be kept clearly visible when revising, and it will be signed by the investigator and dated where there are modifications. All the data can be only obtained by the study researcher who have signed the confidential disclosure agreement. Data without patients’ private information will be published after the study. The adherence to the study protocol, data collection, statistical analysis as well as related safe issues will be strictly monitored by the Institutional Ethic Committee of West China Hospital, SiChuan University.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-09-25
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