ChiCTR2500100759 版本V1.0 版本创建时间2025/04/15 10:12:03 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：

ChiCTR2500100759 

最近更新日期：

Date of Last Refreshed on：

2025-04-15 10:10:53 

注册时间：

Date of Registration：

2025-04-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

性别因素对磷丙泊酚二钠抑制胃镜置入反应效力的影响

Public title：

Effect of sex factors on inhibitory effect of fospropofol disodium on gastroscopy implantation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

性别因素对磷丙泊酚二钠抑制胃镜置入反应效力的影响

Scientific title：

Effect of sex factors on inhibitory effect of fospropofol disodium on gastroscopy implantation

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：

张怡 

研究负责人：

张怡 

Applicant：

Zhang Yi  

Study leader：

Zhang Yi  

申请注册联系人电话：

Applicant telephone：

+86 155 1753 3365

研究负责人电话：

Study leader's telephone：

+86 155 1753 3365

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：

290364006@qq.com

研究负责人电子邮件：

Study leader's E-mail：

290364006@qq.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：

河南省郑州市人民路19号

研究负责人通讯地址：

河南省郑州市人民路19号

Applicant address：

No.19 Renmin Road, Zhengzhou City, Henan Province

Study leader's address：

No.19 Renmin Road, Zhengzhou City, Henan Province

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：

河南中医药大学第一附属医院

Applicant's institution：

The first affiliated hospital of henan university of CM

研究负责人所在单位：

河南中医药大学第一附属医院

Affiliation of the Leader：

The first affiliated hospital of henan university of CM

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025HL-139

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：

河南中医药大学第一附属医院伦理委员会

Name of the ethic committee：

The ethic committee of the first affiliated hospital of henan university of CM

伦理委员会批准日期：

Date of approved by ethic committee：

2025-03-12 00:00:00

伦理委员会联系人：

王春芳

Contact Name of the ethic committee：

Wang Chunfang

伦理委员会联系地址：

河南省郑州市人民路19号

Contact Address of the ethic committee：

No.19 Renmin Road, Zhengzhou City, Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 371 6628 5929

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：

河南中医药大学第一附属医院

Primary sponsor：

The first affiliated hospital of henan university of CM

研究实施负责（组长）单位地址：

河南省郑州市人民路19号

Primary sponsor's address：

No.19 Renmin Road, Zhengzhou City, Henan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河南

市(区县)：

Country：

China

Province：

Henan

City：

单位(医院)：

河南中医药大学第一附属医院

具体地址：

河南省郑州市人民路19号

Institution
hospital：

The first affiliated hospital of henan university of CM

Address：

No.19 Renmin Road, Zhengzhou City, Henan Province

经费或物资来源：

宜昌人福药业有限责任公司

Source(s) of funding：

YICHANG HUMANWELL PHARMACEUTICAL CO.,LTD.

Target disease：

Upper digestive tract disease

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：

单臂 

Study design：

Single arm 

研究目的：

评价性别因素对复合纳布啡时磷丙泊酚二钠抑制胃镜置入反应效力的影响  

Objectives of Study：

To evaluate the effect of gender factors on the inhibitory effect of propofol disodium combined with nalbuphine on gastroscopic implantation.

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.能理解并签署知情同意书； 2.年龄18～64岁； 3.ASA 分级为Ⅰ或Ⅱ级； 4.BMI 18～ 25 kg /m^2 5.对研究用药无过敏、不耐受情况； 6.符合胃镜检查的适应症； 7.未参与其他临床研究。

Inclusion criteria

1. Able to understand and sign informed consent; 2. Age 18-64 years old; 3. ASA grade Ⅰ or Ⅱ; 4. BMI 18-25 kg /m^2 5. No allergy or intolerance to the investigational drug; 6. meet the indications of gastroscopy; 7. Did not participate in other clinical studies.

排除标准：

1.孕产妇； 2.哮喘病史者； 3.酒精滥用者； 4.食管癌患者； 5.患有精神疾病、交流障碍者； 6.血清碱性磷酸酶异常； 7.阿片类药物服用史的患者。

Exclusion criteria：

1. pregnant women; 2. Asthmatic history; 3. Alcohol abusers; 4. Patients with esophageal cancer; 5. People with mental illness and communication disorders; 6. Abnormal serum alkaline phosphatase; 7. Patients with a history of opioid use.

研究实施时间：

Study execute time：

从 From 2025-04-16 00:00:00至 To 2026-05-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-04-16 00:00:00 至 To 2026-05-30 00:00:00  

干预措施：

Interventions：

组别：

男性组

样本量：

35

Group：

Group M

Sample size：

干预措施：

所有男性患者入室后监测 ECG、SpO2 、RR和BP，麻醉时静脉注射纳布啡0.2mg/kg，1min后注射序贯法对应剂量的磷丙泊酚二钠，待改良警觉镇静评分（MOAA /S）≤3分后开始行胃镜检查。按照改良 Dixon 序贯法确定每例患者磷丙泊酚二钠的给药剂量，首例患者根据药品说明书设定为10 mg/kg，下一例患者的给药剂量由上一例患者的反应决定，剂量梯度为0.5 mg /kg。若进镜时患者出现吞咽、呛咳、体动等影响检查操作的反应判定为阳性，否则判定为阴性。如患者反应阴性，则下一例患者剂量降低 0.5 mg/kg；如患者反应阳性，则下一例患者剂量增加 0.5 mg/kg ，直至出现7个阳性反应和阴性反应交替时结束试验。

干预措施代码：

Intervention：

ECG, SpO2, RR and BP were monitored after admission of male patients. Nalbuphine was injected intravenously at 0.2mg/kg during anesthesia, and the sequential dose of propofol disodium was injected 1min later. Gastroscopy was performed after the modified alert sedation score (MOAA /S) was less than 3 points. The dosage of fopropofol disodium was determined according to the modified Dixon sequential method for each patient. The dosage of the first patient was set at 10 mg/kg according to the drug instructions, and the dosage of the next patient was determined by the reaction of the previous patient, with a dose gradient of 0.5 mg/kg. If the patient has swallowing, coughing, body movement and other reactions that affect the examination operation, it is judged to be positive, otherwise it is judged to be negative. If the patient has a negative response, the dose of the next patient is reduced by 0.5 mg/kg; If the patient responds positively, the dose of the next patient is increased by 0.5 mg/kg until the trial is terminated when 7 positive and negative reactions alternate.

Intervention code：

组别：

女性组

样本量：

32

Group：

Group F

Sample size：

干预措施：

所有女性患者入室后监测 ECG、SpO2 、RR和BP，麻醉时静脉注射纳布啡0.2mg/kg，1min后注射序贯法对应剂量的磷丙泊酚二钠，待改良警觉镇静评分（MOAA /S）≤3分后开始行胃镜检查。按照改良 Dixon 序贯法确定每例患者磷丙泊酚二钠的给药剂量，首例患者根据药品说明书设定为10 mg/kg，下一例患者的给药剂量由上一例患者的反应决定，剂量梯度为0.5 mg /kg。若进镜时患者出现吞咽、呛咳、体动等影响检查操作的反应判定为阳性，否则判定为阴性。如患者反应阴性，则下一例患者剂量降低 0.5 mg/kg；如患者反应阳性，则下一例患者剂量增加 0.5 mg/kg ，直至出现7个阳性反应和阴性反应交替时结束试验。

干预措施代码：

Intervention：

ECG, SpO2, RR and BP were monitored after admission of female patients. Nalbuphine was injected intravenously at 0.2mg/kg during anesthesia, and the sequential dose of propofol disodium was injected 1min later. Gastroscopy was performed after the modified alert sedation score (MOAA /S) was less than 3 points. The dosage of fopropofol disodium was determined according to the modified Dixon sequential method for each patient. The dosage of the first patient was set at 10 mg/kg according to the drug instructions, and the dosage of the next patient was determined by the reaction of the previous patient, with a dose gradient of 0.5 mg/kg. If the patient has swallowing, coughing, body movement and other reactions that affect the examination operation, it is judged to be positive, otherwise it is judged to be negative. If the patient has a negative response, the dose of the next patient is reduced by 0.5 mg/kg; If the patient responds positively, the dose of the next patient is increased by 0.5 mg/kg until the trial is terminated when 7 positive and negative reactions alternate.

Intervention code：

组别：

性别不限组

样本量：

33

Group：

Group C

Sample size：

干预措施：

所有患者入室后监测 ECG、SpO2 、RR和BP，麻醉时静脉注射纳布啡0.2mg/kg，1min后注射序贯法对应剂量的磷丙泊酚二钠，待改良警觉镇静评分（MOAA /S）≤3分后开始行胃镜检查。按照改良 Dixon 序贯法确定每例患者磷丙泊酚二钠的给药剂量，首例患者根据药品说明书设定为10 mg/kg，下一例患者的给药剂量由上一例患者的反应决定，剂量梯度为0.5 mg /kg。若进镜时患者出现吞咽、呛咳、体动等影响检查操作的反应判定为阳性，否则判定为阴性。如患者反应阴性，则下一例患者剂量降低 0.5 mg/kg；如患者反应阳性，则下一例患者剂量增加 0.5 mg/kg ，直至出现7个阳性反应和阴性反应交替时结束试验。

干预措施代码：

Intervention：

ECG, SpO2, RR and BP were monitored after admission of patients. Nalbuphine was injected intravenously at 0.2mg/kg during anesthesia, and the sequential dose of propofol disodium was injected 1min later. Gastroscopy was performed after the modified alert sedation score (MOAA /S) was less than 3 points. The dosage of fopropofol disodium was determined according to the modified Dixon sequential method for each patient. The dosage of the first patient was set at 10 mg/kg according to the drug instructions, and the dosage of the next patient was determined by the reaction of the previous patient, with a dose gradient of 0.5 mg/kg. If the patient has swallowing, coughing, body movement and other reactions that affect the examination operation, it is judged to be positive, otherwise it is judged to be negative. If the patient has a negative response, the dose of the next patient is reduced by 0.5 mg/kg; If the patient responds positively, the dose of the next patient is increased by 0.5 mg/kg until the trial is terminated when 7 positive and negative reactions alternate.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

  

Country：

China 

Province：

Henan 

City：

 

单位(医院)：

河南中医药大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The first affiliated hospital of henan university of CM

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

改良警觉镇静评分

指标类型：

主要指标

Outcome：

the modified observer’s assessment of alertness and sedation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血压

指标类型：

次要指标

Outcome：

blood pressure

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 64 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：

Blinding：

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

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）：

不共享

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

no

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：

以病例报告表的形式保存病人信息，并以电子表格的形式储存。

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

Patient information is stored in the form of a case report and in the form of a spreadsheet.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-04-15 10:10:53