ChiCTR2600124717 版本V1.1 版本创建时间2026/05/15 17:32:24 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：

 ChiCTR2600124717 

最近更新日期：

Date of Last Refreshed on：

 2026-05-15 17:32:11 

注册时间：

Date of Registration：

 2026-05-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

泰吉利定联合环泊酚用于无痛胃镜麻醉的量效研究 —-基于改良Dixon法的不同年龄人群ED50和ED95测定

Public title：

Dose-effect study of tamazepine combined with propofol for painless gastroscopy anesthesia - determination of ED50 and ED95 in different age groups based on the modified Dixon method

注册题目简写：

泰吉利定联合环泊酚用于无痛胃镜麻醉对不同年龄人群ED50和ED95测定研究

English Acronym：

Study on the determination of ED50 and ED95 of tamazepam combined with propofol for painless gastroscopy anesthesia in different age groups

研究课题的正式科学名称：

泰吉利定联合环泊酚用于无痛胃镜麻醉的量效研究 —-基于改良Dixon法的不同年龄人群ED50和ED95测定

Scientific title：

Dose-effect study of tamazepine combined with propofol for painless gastroscopy anesthesia - determination of ED50 and ED95 in different age groups based on the modified Dixon method

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：

王煜 

研究负责人：

王煜 

Applicant：

Wang Yu 

Study leader：

Wang Yu 

申请注册联系人电话：

Applicant telephone：

 +86 139 9101 2233

研究负责人电话：

Study leader's
telephone：

+86 139 9101 2233

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：

 13991012233@163.com

研究负责人电子邮件：

Study leader's E-mail：

 13991012233@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：

中国陕西省咸阳市渭城区人民东路78号

研究负责人通讯地址：

中国陕西省咸阳市渭城区人民东路78号

Applicant address：

78 Renmin East Road, Weicheng District, Xianyang, Shaanxi, China

Study leader's address：

78 Renmin East Road, Weicheng District, Xianyang, Shaanxi, 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：

咸阳市中心医院

Applicant's institution：

Xianyang Central Hospital

研究负责人所在单位：

咸阳市中心医院

Affiliation of the Leader：

Xianyang Central 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：

 2026-IRB-51

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：

咸阳市中心医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Xianyang Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-18 00:00:00

伦理委员会联系人：

王燕

Contact Name of the ethic committee：

Wang Yan

伦理委员会联系地址：

中国陕西省咸阳市渭城区人民东路78号

Contact Address of the ethic committee：

78 Renmin East Road, Weicheng District, Xianyang, Shaanxi, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 33288642

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：

咸阳市中心医院

Primary sponsor：

Xianyang Central Hospital

研究实施负责（组长）单位地址：

中国陕西省咸阳市渭城区人民东路78号

Primary sponsor's address：

78 Renmin East Road, Weicheng District, Xianyang, Shaanxi, 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)：

陕西

市(区县)：

咸阳

Country：

China

Province：

Shaanxi

City：

Xianyang

单位(医院)：

咸阳市中心医院

具体地址：

中国陕西省咸阳市渭城区人民东路78号

Institution
hospital：

Xianyang Central Hospital

Address：

78 Renmin East Road, Weicheng District, Xianyang, Shaanxi, China

经费或物资来源：

国家卫生健康委能力建设和继续教育中心

Source(s) of funding：

National Health Commission Capacity Building and Continuing Education Center

研究疾病：

消化系统疾病需做无痛胃肠镜患者  

Target disease：

Patients with digestive system diseases who need painless gastroscopy

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：

 其它 

Study phase：

N/A

研究设计：

不同剂量对照 

Study design：

Dose comparison 

研究目的：

1. 确定泰吉利定（Tegileridine）与环泊酚（Cypofol）联合用于无痛胃镜检查时，抑制胃镜插入反应的50%有效剂量（ED50）和95%有效剂量（ED95）。 2. 探索“富马酸泰吉利定+环泊酚”作为门诊无痛胃肠镜麻醉的标准化流程，为门诊舒适化诊疗提供新的麻醉方案参考。 3. 基于研究结果，为老年患者门诊无痛胃肠镜麻醉提供一种更安全、更优化的镇痛-镇静联合用药方案的循证医学依据。  

Objectives of Study：

1. Determine the 50% effective dose (ED50) and 95% effective dose (ED95) of Tegileridine combined with Cypofol for inhibiting the gastroscopy insertion reaction during painless gastroscopy. 2. Explore the use of "Telitacilic acid + Ciboprofen" as a standardized process for outpatient painless gastroscopy anesthesia, providing a new anesthesia protocol reference for outpatient comfortable diagnosis and treatment. 3. Based on the research results, provide evidence-based medical support for a safer and optimized combined analgesia-sedation medication regimen for outpatient painless gastroscopy anesthesia in elderly patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 年龄18-65岁；2. ASA I-II级；3. BMI 18-30 kg/m^2；4. 于择期镇静麻醉下行胃肠镜检查的患者。

Inclusion criteria

1. Aged 18-65 years old; 2. ASA physical status I-II; 3. BMI 18-30 kg/m^2; 4. Patients undergoing gastroscopy under sedation anesthesia at an elective time.

排除标准：

1. 拒绝签署知情同意书； 2. 预期困难气道； 3. 已知对本研究使用的药物及成分过敏； 4. 已知或可疑的胃肠道梗阻； 5. 急性或重度支气管哮喘； 6. 严重肝肾功能不全； 7. 长期服用阿片类药物。

Exclusion criteria：

1. Refusal to sign the informed consent form; 2. Expected difficult airway; 3. Known allergy to the drugs and components used in this study; 4. Known or suspected gastrointestinal obstruction; 5. Acute or severe bronchial asthma; 6. Severe hepatic and renal insufficiency; 7. Long-term use of opioids.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2026-09-30 00:00:00

干预措施：

Interventions：

组别：

青年组18-44岁

样本量：

 30

Group：

Youth group 18-44 years old

Sample size：

干预措施：

本研究使用改良Dixon序贯法测量药物的半数有效剂量，如果插入胃镜反应阳性，则下一例泰吉利定的剂量增加一个浓度梯度；如果插入胃镜反应阴性，则下一例泰吉利定的剂量降低一个浓度梯度，确定出现了插管反应阳性的病例序号以及该序号的剂量，而入选病例以出现插管反应阳性的前1例患者开始计算，直至出现插入胃镜阴性反应与阳性反应交替8个转折点结束实验，总例数则为研究例数。按年龄将患者分为青年组（18～44岁）、中年组（45～64岁）、老年组（>=65岁），三组独立进行序贯剂量滴定。所有患者均给予固定剂量环泊酚0.3 mg/kg静脉注射，联合滴定不同剂量泰吉利定。以胃镜操作过程中无体动、无呛咳、无躁动为有效判定终点，记录有效/无效结果并序贯调整下一例给药剂量。青年组起始剂量10 μg/kg，剂量梯度1.0 μg/kg。

干预措施代码：

Intervention：

This study employed the modified Dixon sequential method to measure the half-maximal effective dose of the drug. If the gastroscopy insertion response was positive, the dose of the next case of tizoxanide was increased by one concentration gradient; if the gastroscopy insertion response was negative, the dose of the next case of tizoxanide was decreased by one concentration gradient. The case number and dose corresponding to the positive gastroscopy insertion response were determined. The enrolled cases were counted from the first case with a positive gastroscopy insertion response until the experiment ended with eight turning points alternating between negative and positive gastroscopy insertion responses. The total number of cases was the number of study cases. Patients were divided into three groups based on age: young group (18-44 years old), middle-aged group (45-64 years old), and elderly group (>=65 years old). Sequential dose titration was conducted independently in each group. All patients received a fixed dose of 0.3 mg/kg of propofol intravenously, combined with titration of different doses of tizoxanide. The effective endpoint was defined as no body movement, no coughing, and no agitation during gastroscopy. Effective/ineffective results were recorded, and the next dose was sequentially adjusted. The starting dose for the young group was 10 μg/kg, with a dose gradient of 1.0 μg/kg.

Intervention code：

组别：

中年组45-64岁，

样本量：

 30

Group：

Middle-aged group (45-64 years

Sample size：

干预措施：

本研究使用改良Dixon序贯法测量药物的半数有效剂量，如果插入胃镜反应阳性，则下一例泰吉利定的剂量增加一个浓度梯度；如果插入胃镜反应阴性，则下一例泰吉利定的剂量降低一个浓度梯度，确定出现了插管反应阳性的病例序号以及该序号的剂量，而入选病例以出现插管反应阳性的前1例患者开始计算，直至出现插入胃镜阴性反应与阳性反应交替8个转折点结束实验，总例数则为研究例数。按年龄将患者分为青年组（18～44岁）、中年组（45～64岁）、老年组（>=65岁），三组独立进行序贯剂量滴定。所有患者均给予固定剂量环泊酚0.3 mg/kg静脉注射，联合滴定不同剂量泰吉利定。以胃镜操作过程中无体动、无呛咳、无躁动为有效判定终点，记录有效/无效结果并序贯调整下一例给药剂量。中年组起始剂量9 μg/kg，剂量梯度1.0 μg/kg。

干预措施代码：

Intervention：

This study employed the modified Dixon sequential method to measure the half-maximal effective dose of the drug. If the gastroscopy insertion response was positive, the dose of the next case of tizoxanide was increased by one concentration gradient; if the gastroscopy insertion response was negative, the dose of the next case of tizoxanide was decreased by one concentration gradient. The case number and dose corresponding to the positive gastroscopy insertion response were determined. The enrolled cases were counted from the first case with a positive gastroscopy insertion response until the experiment ended with eight turning points where positive and negative gastroscopy insertion responses alternated. The total number of cases was the number of study cases. Patients were divided into three groups based on age: young group (18-44 years old), middle-aged group (45-64 years old), and elderly group (>=65 years old). Sequential dose titration was conducted independently in each group. All patients received a fixed dose of 0.3 mg/kg of propofol intravenously, combined with titration of different doses of tizoxanide. The absence of body movement, coughing, and agitation during gastroscopy was used as the effective endpoint for determining whether the treatment was effective or ineffective, and the next dose was sequentially adjusted accordingly. The starting dose for the middle-aged group was 9 μg/kg, with a dose gradient of 1.0 μg/kg

Intervention code：

组别：

老年组>=65岁

样本量：

 30

Group：

Elderly group (>=65 years old)

Sample size：

干预措施：

本研究使用改良Dixon序贯法测量药物的半数有效剂量，如果插入胃镜反应阳性，则下一例泰吉利定的剂量增加一个浓度梯度；如果插入胃镜反应阴性，则下一例泰吉利定的剂量降低一个浓度梯度，确定出现了插管反应阳性的病例序号以及该序号的剂量，而入选病例以出现插管反应阳性的前1例患者开始计算，直至出现插入胃镜阴性反应与阳性反应交替8个转折点结束实验，总例数则为研究例数。按年龄将患者分为青年组（18～44岁）、中年组（45～64岁）、老年组（>=65岁），三组独立进行序贯剂量滴定。所有患者均给予固定剂量环泊酚0.3 mg/kg静脉注射，联合滴定不同剂量泰吉利定。以胃镜操作过程中无体动、无呛咳、无躁动为有效判定终点，记录有效/无效结果并序贯调整下一例给药剂量。老年组起始剂量8 μg/kg，剂量梯度1.0 μg/kg。

干预措施代码：

Intervention：

This study employed the modified Dixon sequential method to measure the median effective dose of the drug. If the gastroscopy insertion response was positive, the dose of the next case of tizoxanide was increased by one concentration gradient; if the gastroscopy insertion response was negative, the dose of the next case of tizoxanide was decreased by one concentration gradient. The case number and dose corresponding to the positive gastroscopy insertion response were determined. The enrolled cases were counted from the first case with a positive gastroscopy insertion response until the experiment ended with eight turning points where positive and negative gastroscopy insertion responses alternated. The total number of cases was the number of study cases. Patients were divided into three groups based on age: young group (18-44 years old), middle-aged group (45-64 years old), and elderly group (>=65 years old). Sequential dose titration was conducted independently in the three groups. All patients received a fixed dose of 0.3 mg/kg of propofol intravenously, combined with titration of different doses of tizoxanide. The effective endpoint was defined as no body movement, no coughing, and no agitation during gastroscopy. Effective/ineffective results were recorded, and the next dose was sequentially adjusted. The starting dose for the elderly group was 8 μg/kg, with a dose gradient of 1.0 μg/kg.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

 咸阳 

Country：

China

Province：

Shaanxi

City：

Xianyang

单位(医院)：

 咸阳市中心医院 

单位级别：

 三甲 

Institution
hospital：

Xianyang Central Hospital

Level of the institution：

top three

测量指标：

Outcomes：

指标中文名：

ED50、ED95

指标类型：

主要指标

Outcome：

ED50 and ED95

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心率（HR）、血氧饱和度（SpO2）和平均动脉压（MAP）

指标类型：

次要指标

Outcome：

Heart rate (HR), oxygen saturation (SpO2), and mean arterial pressure (MAP)

Type：

Secondary indicator

测量时间点：

基线（T0）、诱导后时间（T1）、完成时间（T2）和离开时间（T3）

测量方法：

Measure time point of outcome：

Baseline (T0), post-induction (T1), completion (T2), and discharge (T3)

Measure method：

指标中文名：

辅助气道操作的次数

指标类型：

次要指标

Outcome：

Number of airway assistance procedures

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

因持续低氧血症取出胃镜的次数

指标类型：

次要指标

Outcome：

Number of endoscopy withdrawals due to persistent hypoxemia

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

眩晕、恶心、呕吐的次数及时间

指标类型：

次要指标

Outcome：

Frequency and duration of dizziness, nausea, and vomiting

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者满意度及内镜操作医师满意度

指标类型：

次要指标

Outcome：

Patient and endoscopist satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

环泊酚的诱导剂量和总给药剂量、泰吉利定的剂量、成功诱导的时间、胃镜检查持续时间（从插入内镜到拔出）以及血管活性药物的给药情况

指标类型：

次要指标

Outcome：

Dose of cycloprofen for induction and total administration, dose of tigecycline, time to successful induction, duration of endoscopy (from insertion to removal of endoscope), and use of vasopressor agents

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 80 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

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

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）：

不共享

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

Do not share

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：

病例记录表

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

Case Record Form, CRF

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：

  2026-05-15 17:32:05