ChiCTR2300077446 版本V1.1 版本创建时间2024/05/27 17:44:12 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300077446 

最近更新日期：

Date of Last Refreshed on：

 2023-11-09 08:57:17 

注册时间：

Date of Registration：

 2023-11-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

TCI丙泊酚镇静下肠镜检查镇痛药物消耗量和患者舒适度的区别:纳布啡?羟考酮和芬太尼的比较研究

Public title：

Difference in analgesic drug consumption and patients' comfort during colonoscopy under TCI propofol sedation: a comparative study of nalbuphine, oxycodone, and fentanyl

注册题目简写：

靶控镇静下不同镇痛药物的消耗量及患者舒适度区别

English Acronym：

Consumption of different analgesics and comfort of patients under target-controlled sedation

研究课题的正式科学名称：

TCI丙泊酚镇静下肠镜检查镇痛药物消耗量和患者舒适度的区别:纳布啡?羟考酮和芬太尼的比较研究

Scientific title：

Difference in analgesic drug consumption and patients' comfort during colonoscopy under TCI propofol sedation: a comparative study of nalbuphine, oxycodone, and fentanyl

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：

侯春柳 

研究负责人：

李岩 

Applicant：

Chunliu Hou 

Study leader：

Yan Li 

申请注册联系人电话：

Applicant telephone：

 +86 22 6011 1202

研究负责人电话：

Study leader's
telephone：

+86 22 6011 1202

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：

 2088954151@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 drliyan@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：

山西省太原市迎泽区新建南路56号

研究负责人通讯地址：

天津市蓟州区南环路18号

Applicant address：

56 Xinjian South Road, Yingze District, Taiyuan City, Shanxi Province

Study leader's address：

No.18 South Ring Road, Jizhou District, Tianjin

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：

山西医科大学

Applicant's institution：

Shanxi Medical University

研究负责人所在单位：

天津市蓟州区人民医院

Affiliation of the Leader：

Tianjin Jizhou District People's 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：

 IRB2023-18

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：

天津市蓟州区人民医院医学伦理委员会

Name of the ethic committee：

Tianjin Jizhou District People's Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-22 00:00:00

伦理委员会联系人：

王立凤

Contact Name of the ethic committee：

Lifeng Wang

伦理委员会联系地址：

天津市蓟州区南环路18号

Contact Address of the ethic committee：

No.18 South Ring Road, Jizhou District, Tianjin

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 22 6011 1202

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：

天津市蓟州区人民医院

Primary sponsor：

Tianjin Jizhou District People's Hospital

研究实施负责（组长）单位地址：

天津市蓟州区南环路18号

Primary sponsor's address：

No.18 South Ring Road, Jizhou District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津市

市(区县)：

蓟州区

Country：

China

Province：

Tianjin

City：

Jizhou

单位(医院)：

天津市蓟州区人民医院

具体地址：

天津市蓟州区南环路18号

Institution
hospital：

Tianjin Jizhou District People's Hospital

Address：

No.18 South Ring Road, Jizhou District, Tianjin

经费或物资来源：

天津市蓟州区人民医院

Source(s) of funding：

Tianjin Jizhou District People's Hospital

研究疾病：

无痛肠镜围检查期腹痛  

Target disease：

Abdominal pain during a painless colonoscopy

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：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟于检查前给予合适剂量的纳布啡?羟考酮和芬太尼,观察三者对肠镜检查时患者药物使用量的区别?各项监测指标的变化?检查后恢复情况及不良反应发生率的区别?  

Objectives of Study：

In this study, appropriate doses of nalbuphine, oxycodone and fentanyl were administered before examination to observe the differences in drug use, changes in various monitoring indicators, recovery after examination and the incidence of adverse reactions among patients during colonoscopy.

药物成份或治疗方案详述：

麻醉诱导时根据既往试验研究数据确定,分别给予纳布啡,羟考酮和芬太尼注射液,各组首例患者剂量分别纳布啡0.1mg/kg,羟考酮0.07mg/kg,芬太尼0.01mg/kg,2min后3组均给予丙泊酚TCI血浆浓度(Marsh模型)血浆靶浓度4μg/mL静脉输注,待患者RamsayⅡ级后设置靶浓度2.5μg/mL持续泵注,后进行肠镜检查?观察入镜时体动发生情况?体动分为3级:1级,轻微不自主地肢体运动,不影响内镜检查,无需追加丙泊酚;2级,患者躁动,影响内镜检查,需追加麻醉药物抑制;3级,非常躁动,完全不能配合,需终止检查退镜,加深麻醉后继续?患者麻醉诱导后入镜时体动出现2级及以上为检查阳性,否则为阴性? 每组如前一例患者阳性,则下一例患者剂量增加0.01mg/kg,反之减少0.01mg/kg?待第8次阴性转为阳性结果出现时,终止序贯法,得出精确的镇痛药物有效剂量? 

Description for medicine or protocol of treatment in detail：

During anesthesia induction, according to previous experimental and research data, nalbuphine, oxycodone and fentanyl injection were given respectively, and the dosage of the first patient in each group was 0.1mg/kg of nalbuphine, 0.07mg/kg of oxycodone and 0.01mg/kg of fentanyl. After 2min, propofol TCI plasma concentration (Ma) was given to all three groups rsh model) plasma target concentration 4μg/mL intravenous infusion, after the patient RamsayⅡ level was set up target concentration 2.5μg/mL continuous pumping, then colonoscopy was performed. Observe the body movement when entering the mirror. Body movement is divided into 3 levels :1, slight involuntary limb movement, does not affect endoscopy, no need to add propofol; Grade 2: The patient is agitated, which affects endoscopy, and needs to be inhibited by additional anesthetic drugs; Grade 3, very agitated, completely unable to cooperate, need to terminate the examination and withdrawal, further anesthesia after continuing. After induction of anesthesia, the patient's body movement level 2 or above was positive, otherwise it was negative. In each group, if the previous patient was positive, the dose of the next patient was increased by 0.01mg/kg, and vice versa, decreased by 0.01mg/kg. When the eighth negative to positive result appears, the sequential method is terminated and the accurate effective dose of analgesic drugs is obtained. 

纳入标准：

入选标准 1)行纤维结肠镜检查; 2)患者主动要求行静脉麻醉; 3)性别不限,年龄18-65岁; 4)ASAⅠ或Ⅱ级; 5)签署知情同意书

Inclusion criteria

Inclusion criteria 1) Fibercolonoscopy was performed; 2) The patient voluntarily requested intravenous anesthesia; 3) Regardless of gender, age 18-65 years old; 4)ASAⅠ or Ⅱ level; 5) Sign informed consent

排除标准：

排除标准 1)患者存在神经系统疾病或精神病史,药物过敏史; 2)1个月内手术史; 3)镇痛药物长期服用史或其他影响试验结果的服药史; 4)未控制的高血压?心律失常和心力衰竭等病史; 5)阻塞性睡眠性呼吸暂停(OSA)?急性上呼吸道感染?哮喘等呼吸系统疾病史; 6)根据研究者的判断,属于除入选标准和排除标准以外的因其它任何原因而不适合参加本研究的患者?

Exclusion criteria：

Exclusion criteria 1) The patient has a history of neurological disease or mental illness and a history of drug allergy; 2) Surgical history within 1 month; 3) History of long-term use of analgesic drugs or other history of taking drugs that affect the test results; 4) A history of uncontrolled hypertension, arrhythmia, and heart failure; 5) History of obstructive sleep apnea (OSA), acute upper respiratory tract infection, asthma and other respiratory diseases; 6) According to the judgment of the investigator, patients who are not suitable for participation in this study for any reason other than the inclusion criteria and exclusion criteria.

研究实施时间：

Study execute time：

从 From 2023-08-01 00:00:00至 To 2024-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-09 00:00:00 至 To 2024-06-01 00:00:00

干预措施：

Interventions：

组别：

实验1组

样本量：

 33

Group：

Experiment group 1

Sample size：

干预措施：

检查前给予纳布啡

干预措施代码：

 N

Intervention：

Nalbuphine was given before examination

Intervention code：

组别：

实验2组

样本量：

 33

Group：

Experiment group 2

Sample size：

干预措施：

检查前给予羟考酮

干预措施代码：

 O

Intervention：

Oxycodone was given before examination

Intervention code：

组别：

对照组

样本量：

 33

Group：

control group

Sample size：

干预措施：

检查前给予芬太尼

干预措施代码：

 F

Intervention：

Fentanyl was given before examination

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津市 

市(区县)：

 蓟州区 

Country：

China

Province：

Tianjin

City：

Jizhou

单位(医院)：

 天津市蓟州区人民医院 

单位级别：

 三甲 

Institution
hospital：

Tianjin Jizhou District People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

镇痛药物(纳布啡,羟考酮,芬太尼)总使用量/mg

指标类型：

主要指标

Outcome：

Total use of analgesics (nalbuphine, oxycodone, fentanyl) /mg

Type：

Primary indicator

测量时间点：

纤维结肠镜退镜时

测量方法：

药物剂量记录

Measure time point of outcome：

When the fibercolonoscopy was withdrawn

Measure method：

dose-recording

指标中文名：

平均动脉压

指标类型：

次要指标

Outcome：

MAP

Type：

Secondary indicator

测量时间点：

诱导前(TO),诱导后2min(T1),进镜时(T2),过结肠曲(T3),过脾曲(T4),过回盲部(T5),退镜时(T6)

测量方法：

监护仪记录

Measure time point of outcome：

preinduction(TO),2min after induction(T1),When the fibercolonoscopy came in(T2),Over flexure of the colon (T3), over flexure of the spleen (T4), over ileocecal part (T5), at withdrawal (T6)

Measure method：

Monitor recording

指标中文名：

心率

指标类型：

次要指标

Outcome：

HR

Type：

Secondary indicator

测量时间点：

诱导前(TO),诱导后2min(T1),进镜时(T2),过结肠曲(T3),过脾曲(T4),过回盲部(T5),退镜时(T6)

测量方法：

监护仪记录

Measure time point of outcome：

preinduction(TO),2min after induction(T1),When the fibercolonoscopy came in(T2),Over flexure of the colon (T3), over flexure of the spleen (T4), over ileocecal part (T5), at withdrawal (T6)

Measure method：

Monitor recording

指标中文名：

指脉氧饱和度

指标类型：

次要指标

Outcome：

SpO2

Type：

Secondary indicator

测量时间点：

诱导前(TO),诱导后2min(T1),进镜时(T2),过结肠曲(T3),过脾曲(T4),过回盲部(T5),退镜时(T6)

测量方法：

监护仪记录

Measure time point of outcome：

preinduction(TO),2min after induction(T1),When the fibercolonoscopy came in(T2),Over flexure of the colon (T3), over flexure of the spleen (T4), over ileocecal part (T5), at withdrawal (T6)

Measure method：

Monitor recording

指标中文名：

呼吸情况(是否需要面罩加压给氧/气管插管)

指标类型：

次要指标

Outcome：

Breathing (whether mask pressure is required for oxygen/trachea intubation)

Type：

Secondary indicator

测量时间点：

诱导前(TO),诱导后2min(T1),进镜时(T2),过结肠曲(T3),过脾曲(T4),过回盲部(T5),退镜时(T6)

测量方法：

症状记录

Measure time point of outcome：

preinduction(TO),2min after induction(T1),When the fibercolonoscopy came in(T2),Over flexure of the colon (T3), over flexure of the spleen (T4), over ileocecal part (T5), at withdrawal (T6)

Measure method：

symptom records

指标中文名：

体动反应分级

指标类型：

次要指标

Outcome：

body motion grade

Type：

Secondary indicator

测量时间点：

诱导前(TO),诱导后2min(T1),进镜时(T2),过结肠曲(T3),过脾曲(T4),过回盲部(T5),退镜时(T6)

测量方法：

症状记录

Measure time point of outcome：

preinduction(TO),2min after induction(T1),When the fibercolonoscopy came in(T2),Over flexure of the colon (T3), over flexure of the spleen (T4), over ileocecal part (T5), at withdrawal (T6)

Measure method：

symptom records

指标中文名：

是否躁动

指标类型：

次要指标

Outcome：

Whether restless or not

Type：

Secondary indicator

测量时间点：

诱导前(TO),诱导后2min(T1),进镜时(T2),过结肠曲(T3),过脾曲(T4),过回盲部(T5),退镜时(T6)

测量方法：

症状记录

Measure time point of outcome：

preinduction(TO),2min after induction(T1),When the fibercolonoscopy came in(T2),Over flexure of the colon (T3), over flexure of the spleen (T4), over ileocecal part (T5), at withdrawal (T6)

Measure method：

symptom records

指标中文名：

不适症状

指标类型：

副作用指标

Outcome：

discomfort

Type：

Adverse events

测量时间点：

检查结束后20min内

测量方法：

症状记录

Measure time point of outcome：

Within 20 minutes after the check completed

Measure method：

symptom records

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

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 岁 years
最大 Max age 65 岁 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）：

研究者使用计算机随机数生成器，生成随机数

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

The researchers used a computer random number generator to generate random numbers

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

患者接受相同的教育信息,确保他们不知道自己的治疗方式?实验组和对照组之间没有明显差异,因此对参与研究的内镜医生保持盲法?数据记录者知晓治疗分配但使用盲法数据记录,故数据分析师并不知道治疗分配,所有数据分析均完成后进行解盲?

Blinding：

Receive the same educational information to make sure they are not aware of their own treatment. There was no significant difference between the experimental group and the control group, so the endoscopists participating in the study were kept blind. The data logger is aware of the treatment assignment but uses blind data logging, so the data analyst is not aware of the treatment assignment, and all data analysis is performed after the blind.

是否共享原始数据：

IPD sharing

否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）：

无

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

none

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：

数据使用纸质版和电子版crf表格记录

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

Data were recorded using paper and electronic crf forms

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：

  2023-11-09 08:56:57