中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500114349
最近更新日期： Date of Last Refreshed on：	2025-12-10 16:22:05
注册时间： Date of Registration：	2025-12-10 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	中国儿童UGT1A9基因rs13418420位点多态性对无痛胃镜静脉全麻中长链丙泊酚药效的影响
Public title：	The effect of Chinese children's UGT1A9 gene rs13418420 site polymorphism on the efficacy of medium-long chain propofol in painless gastroscopic venous anesthesia
注册题目简写：
English Acronym：
研究课题的正式科学名称：	中国儿童UGT1A9基因rs13418420位点多态性对无痛胃镜静脉全麻中长链丙泊酚药效的影响
Scientific title：	The effect of Chinese children's UGT1A9 gene rs13418420 site polymorphism on the efficacy of medium-long chain propofol in painless gastroscopic venous anesthesia
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：	王昀	研究负责人：	王昀
Applicant：	Yun Wang	Study leader：	Yun Wang
申请注册联系人电话： Applicant telephone：	+86 20 3915 1759	研究负责人电话： Study leader's telephone：	+86 20 3915 1759
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：	529131440@qq.com	研究负责人电子邮件： Study leader's E-mail：	529131440@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：	广东省广州市番禺区南村镇兴南大道521号	研究负责人通讯地址：	广东省广州市番禺区南村镇兴南大道521号
Applicant address：	No. 521, Xingnan Avenue, Nancun Town, Panyu District, Guangzhou City, Guangdong Province	Study leader's address：	No. 521, Xingnan Avenue, Nancun Town, Panyu District, Guangzhou City, Guangdong 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：	广东省妇幼保健院
Applicant's institution：	Guangdong Provincial Maternal and Child Health Hospital
研究负责人所在单位：	广东省妇幼保健院
Affiliation of the Leader：	Guangdong Provincial Maternal and Child Health 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：	广东省妇幼保健院医伦第[20250031]号	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：	广东省妇幼保健院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Guangdong Women and Children Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-03-20 00:00:00
伦理委员会联系人：	陈园
Contact Name of the ethic committee：	Yuan Chen
伦理委员会联系地址：	广东省广州市番禺区南村镇兴南大道521号
Contact Address of the ethic committee：	No. 521, Xingnan Avenue, Nancun Town, Panyu District, Guangzhou City, Guangdong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 39151602	伦理委员会联系人邮箱： Contact email of the ethic committee：	cheny6038@163.com

研究实施负责（组长）单位：

广东省妇幼保健院

Primary sponsor：

Guangdong Provincial Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

广东省广州市番禺区南村镇兴南大道521号

Primary sponsor's address：

No. 521, Xingnan Avenue, Nancun Town, Panyu District, Guangzhou City, Guangdong 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)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广东省妇幼保健院(广东省妇产医院、广东省儿童医院)	具体地址：	广东省广州市番禺区南村镇兴南大道521号
Institution hospital：	Guangdong Province Hospital for Women and Children Healthcare	Address：	No. 521, Xingnan Avenue, Nancun Town, Panyu District, Guangzhou City, Guangdong Province

经费或物资来源：

2023年度广东省基础与应用基础研究基金企业联合基金（公共卫生与医药健康领域）项目计划

Source(s) of funding：

2023 Guangdong Basic and Applied Basic Research Foundation Enterprise Joint Fund

研究疾病：

腹痛；发热

Target disease：

Abdominal pain; fever

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：

非随机对照试验

Study design：

Non randomized control

研究目的：

1.明确UGT1A9基因rs13418420位点多态性与儿童中长链丙泊酚药效的相关性； 2.明确在儿童胃镜检查用中长链丙泊酚实施静脉麻醉诱导时，不同基因型儿童中长链丙泊酚的半数有效量ED50和95%有效量ED95。

Objectives of Study：

To clarify the correlation between the polymorphism of the rs13418420 locus of the UGT1A9 gene and the efficacy of long-chain propofol in children; 2. Clearly define the median effective dose ED50 and 95% effective dose ED95 of medium and long chain propofol in children with different genotypes during intravenous anesthesia induction for gastroscopy in children.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.ASA >= 3 级 2.无法配合静脉诱导 3. 丙泊酚过敏及其他丙泊酚使用禁忌 4.明显神经性缺陷或精神神经系统发育迟缓者根据Griffiths 精神发育量表计算的总发育商＜70 分明显影响认知发育的综合症 5.存在遗传代谢性疾病如先天性甲状腺功能减退症苯丙酮尿症甲基丙二酸血症 6.肝肾功能异常 7.3 个月内参与其他临床研究

Exclusion criteria：

1.ASA >= level 3 2. Unable to cooperate with intravenous induction 3. Propofol allergy and other contraindications for propofol use 4. A syndrome that significantly affects cognitive development, with a total developmental quotient of less than 70 points calculated based on the Griffiths Mental Development Scale for individuals with obvious neurological defects or delayed development of the mental nervous system 5. There are genetic metabolic diseases such as congenital hypothyroidism, phenylketonuria, and methylmalonic acidemia 6. Abnormal liver and kidney functions 7.Participate in other clinical studies within 3 months

研究实施时间：

Study execute time：

从 From 2025-03-20 00:00:00至 To 2026-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-21 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：	女TT组	样本量：	24
Group：	Female TT group	Sample size：	24
干预措施：	将浓度 10mg/ml 的中长链丙泊酚作为试验用药，设定中长链丙泊酚初始剂量为 3mg/kg下一例患儿的丙泊酚诱导量视上一例患儿反应决定相邻间隔剂量为 0.25mg/ml给药后待患儿睫毛反射消失后进行胃镜检查若在进境过程中出现呛咳皱眉体动等阳性反应判为镇静失败则该组下一例患儿接受丙泊酚的诱导剂量递增0.25mg/ml否则判为镇静成功则该组下一例患儿接受丙泊酚的诱导剂量递减0.25mg/ml以剂量上升趋势中出现镇静成功转向镇静失败的患者为第一个转折点随后从失败到成功为第二个转折点如此反复直至出现 7 个转折点终止研究	干预措施代码：
Intervention：	Medium and long-chain propofol with a concentration of 10mg/ml was used as the test drug. The initial dose of medium and long-chain propofol was set at 3mg/kg. The induction dose of propofol for the next child was determined based on the response of the previous child, with the adjacent interval dose being After administration of 0.25mg/ml, gastroscopy was performed after the eyelash reflex of the child disappeared. If positive reactions such as choking, frowning, and body movement occurred during the entry process, it was judged as a failed sedation, and the next child in the group received an increased induction dose of 0.25mg/ml of propofol. Otherwise, it was judged as a successful sedation, and the next child in the group received an decreased induction dose of 0.25mg/ml of propofol The first turning point was the shift from successful sedation to failed sedation in the dose upward trend, followed by the second turning point from failure to success. This process was repeated until seven turning points were reached and the study was terminated	Intervention code：

组别：	女TC组	样本量：	24
Group：	Female TC group	Sample size：	24
干预措施：	将浓度 10mg/ml 的中长链丙泊酚作为试验用药，设定中长链丙泊酚初始剂量为 3mg/kg下一例患儿的丙泊酚诱导量视上一例患儿反应决定相邻间隔剂量为 0.25mg/ml给药后待患儿睫毛反射消失后进行胃镜检查若在进境过程中出现呛咳皱眉体动等阳性反应判为镇静失败则该组下一例患儿接受丙泊酚的诱导剂量递增0.25mg/ml否则判为镇静成功则该组下一例患儿接受丙泊酚的诱导剂量递减0.25mg/ml以剂量上升趋势中出现镇静成功转向镇静失败的患者为第一个转折点随后从失败到成功为第二个转折点如此反复直至出现 7 个转折点终止研究	干预措施代码：
Intervention：	Medium and long-chain propofol with a concentration of 10mg/ml was used as the test drug. The initial dose of medium and long-chain propofol was set at 3mg/kg. The induction dose of propofol for the next child was determined based on the response of the previous child, with the adjacent interval dose being After administration of 0.25mg/ml, gastroscopy was performed after the eyelash reflex of the child disappeared. If positive reactions such as choking, frowning, and body movement occurred during the entry process, it was judged as a failed sedation, and the next child in the group received an increased induction dose of 0.25mg/ml of propofol. Otherwise, it was judged as a successful sedation, and the next child in the group received an decreased induction dose of 0.25mg/ml of propofol The first turning point was the shift from successful sedation to failed sedation in the dose upward trend, followed by the second turning point from failure to success. This process was repeated until seven turning points were reached and the study was terminated	Intervention code：

组别：	男CC组	样本量：	24
Group：	Male CC group	Sample size：	24
干预措施：	将浓度 10mg/ml 的中长链丙泊酚作为试验用药，设定中长链丙泊酚初始剂量为 3mg/kg下一例患儿的丙泊酚诱导量视上一例患儿反应决定相邻间隔剂量为 0.25mg/ml给药后待患儿睫毛反射消失后进行胃镜检查若在进境过程中出现呛咳皱眉体动等阳性反应判为镇静失败则该组下一例患儿接受丙泊酚的诱导剂量递增0.25mg/ml否则判为镇静成功则该组下一例患儿接受丙泊酚的诱导剂量递减0.25mg/ml以剂量上升趋势中出现镇静成功转向镇静失败的患者为第一个转折点随后从失败到成功为第二个转折点如此反复直至出现 7 个转折点终止研究	干预措施代码：
Intervention：	Medium and long-chain propofol with a concentration of 10mg/ml was used as the test drug. The initial dose of medium and long-chain propofol was set at 3mg/kg. The induction dose of propofol for the next child was determined based on the response of the previous child, with the adjacent interval dose being After administration of 0.25mg/ml, gastroscopy was performed after the eyelash reflex of the child disappeared. If positive reactions such as choking, frowning, and body movement occurred during the entry process, it was judged as a failed sedation, and the next child in the group received an increased induction dose of 0.25mg/ml of propofol. Otherwise, it was judged as a successful sedation, and the next child in the group received an decreased induction dose of 0.25mg/ml of propofol The first turning point was the shift from successful sedation to failed sedation in the dose upward trend, followed by the second turning point from failure to success. This process was repeated until seven turning points were reached and the study was terminated	Intervention code：

组别：	男TT组	样本量：	24
Group：	Male TT group	Sample size：	24
干预措施：	将浓度 10mg/ml 的中长链丙泊酚作为试验用药，设定中长链丙泊酚初始剂量为 3mg/kg下一例患儿的丙泊酚诱导量视上一例患儿反应决定相邻间隔剂量为 0.25mg/ml给药后待患儿睫毛反射消失后进行胃镜检查若在进境过程中出现呛咳皱眉体动等阳性反应判为镇静失败则该组下一例患儿接受丙泊酚的诱导剂量递增0.25mg/ml否则判为镇静成功则该组下一例患儿接受丙泊酚的诱导剂量递减0.25mg/ml以剂量上升趋势中出现镇静成功转向镇静失败的患者为第一个转折点随后从失败到成功为第二个转折点如此反复直至出现 7 个转折点终止研究	干预措施代码：
Intervention：	Medium and long-chain propofol with a concentration of 10mg/ml was used as the test drug. The initial dose of medium and long-chain propofol was set at 3mg/kg. The induction dose of propofol for the next child was determined based on the response of the previous child, with the adjacent interval dose being After administration of 0.25mg/ml, gastroscopy was performed after the eyelash reflex of the child disappeared. If positive reactions such as choking, frowning, and body movement occurred during the entry process, it was judged as a failed sedation, and the next child in the group received an increased induction dose of 0.25mg/ml of propofol. Otherwise, it was judged as a successful sedation, and the next child in the group received an decreased induction dose of 0.25mg/ml of propofol The first turning point was the shift from successful sedation to failed sedation in the dose upward trend, followed by the second turning point from failure to success. This process was repeated until seven turning points were reached and the study was terminated	Intervention code：

组别：	男TC组	样本量：	24
Group：	Male TC group	Sample size：	24
干预措施：	将浓度 10mg/ml 的中长链丙泊酚作为试验用药，设定中长链丙泊酚初始剂量为 3mg/kg下一例患儿的丙泊酚诱导量视上一例患儿反应决定相邻间隔剂量为 0.25mg/ml给药后待患儿睫毛反射消失后进行胃镜检查若在进境过程中出现呛咳皱眉体动等阳性反应判为镇静失败则该组下一例患儿接受丙泊酚的诱导剂量递增0.25mg/ml否则判为镇静成功则该组下一例患儿接受丙泊酚的诱导剂量递减0.25mg/ml以剂量上升趋势中出现镇静成功转向镇静失败的患者为第一个转折点随后从失败到成功为第二个转折点如此反复直至出现 7 个转折点终止研究	干预措施代码：
Intervention：	Medium and long-chain propofol with a concentration of 10mg/ml was used as the test drug. The initial dose of medium and long-chain propofol was set at 3mg/kg. The induction dose of propofol for the next child was determined based on the response of the previous child, with the adjacent interval dose being After administration of 0.25mg/ml, gastroscopy was performed after the eyelash reflex of the child disappeared. If positive reactions such as choking, frowning, and body movement occurred during the entry process, it was judged as a failed sedation, and the next child in the group received an increased induction dose of 0.25mg/ml of propofol. Otherwise, it was judged as a successful sedation, and the next child in the group received an decreased induction dose of 0.25mg/ml of propofol The first turning point was the shift from successful sedation to failed sedation in the dose upward trend, followed by the second turning point from failure to success. This process was repeated until seven turning points were reached and the study was terminated	Intervention code：

组别：	女CC组	样本量：	24
Group：	Female CC group	Sample size：	24
干预措施：	将浓度 10mg/ml 的中长链丙泊酚作为试验用药，设定中长链丙泊酚初始剂量为 3mg/kg下一例患儿的丙泊酚诱导量视上一例患儿反应决定相邻间隔剂量为 0.25mg/ml给药后待患儿睫毛反射消失后进行胃镜检查若在进境过程中出现呛咳皱眉体动等阳性反应判为镇静失败则该组下一例患儿接受丙泊酚的诱导剂量递增0.25mg/ml否则判为镇静成功则该组下一例患儿接受丙泊酚的诱导剂量递减0.25mg/ml以剂量上升趋势中出现镇静成功转向镇静失败的患者为第一个转折点随后从失败到成功为第二个转折点如此反复直至出现 7 个转折点终止研究	干预措施代码：
Intervention：	Medium and long-chain propofol with a concentration of 10mg/ml was used as the test drug. The initial dose of medium and long-chain propofol was set at 3mg/kg. The induction dose of propofol for the next child was determined based on the response of the previous child, with the adjacent interval dose being After administration of 0.25mg/ml, gastroscopy was performed after the eyelash reflex of the child disappeared. If positive reactions such as choking, frowning, and body movement occurred during the entry process, it was judged as a failed sedation, and the next child in the group received an increased induction dose of 0.25mg/ml of propofol. Otherwise, it was judged as a successful sedation, and the next child in the group received an decreased induction dose of 0.25mg/ml of propofol The first turning point was the shift from successful sedation to failed sedation in the dose upward trend, followed by the second turning point from failure to success. This process was repeated until seven turning points were reached and the study was terminated	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广东省妇幼保健院	单位级别：	三级甲等
Institution hospital：	Guangdong Provincial Maternal and Child Health Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	围术期的血压	指标类型：	次要指标
Outcome：	Perioperative Blood Pressure	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中长链丙泊酚用于小儿全麻胃镜诱导的ED50	指标类型：	主要指标
Outcome：	ED50 of medium to long chain propofol for induction of pediatric general anesthesia gastroscopy	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中长链丙泊酚每公斤体重单位时间用量	指标类型：	次要指标
Outcome：	Medium-long chain propofol dosage per kilogram of body weight per unit 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：	围术期的心率	指标类型：	次要指标
Outcome：	Perioperative Heart Rate	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：	唾液	组织：
Sample Name：	Saliva	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	5	岁 years
最大 Max age	12	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:

不公开/Private

盲法：	本试验采用双盲；受试者，麻醉医生，数据观察录入人员均不知道受试者分组
Blinding：	This experiment was conducted in a double-blind manner. The subjects, anesthesiologists and data observation and entry personnel were all unaware of the subject groups

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）：	研究结束后，通过ResMan(www.medresman.org.cn)方式共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the end of the study, it was shared by ResMan (www.medresman.org.cn).
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：	CRF;EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF;EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-12-10 16:21:57