ChiCTR2500113063 版本V1.0 版本创建时间2025/11/24 16:04:43 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：

 ChiCTR2500113063 

最近更新日期：

Date of Last Refreshed on：

 2025-11-24 16:04:36 

注册时间：

Date of Registration：

 2025-11-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

氢吗啡酮联合吸入麻醉在小儿斜弱视手术中的应用研究

Public title：

Application of Hydromorphone Combined with Inhalation Anesthesia in Pediatric Amblyopia Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氢吗啡酮联合吸入麻醉在小儿斜弱视手术中的应用研究

Scientific title：

Application of Hydromorphone Combined with Inhalation Anesthesia in Pediatric Amblyopia Surgery

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：

蒋天放 

研究负责人：

蒋天放 

Applicant：

Jiang Tianfang 

Study leader：

Jiang Tianfang 

申请注册联系人电话：

Applicant telephone：

 +86 136 9587 6822

研究负责人电话：

Study leader's
telephone：

+86 136 9587 6822

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：

 13695876822@eye.ac.cn

研究负责人电子邮件：

Study leader's E-mail：

 13695876822@eye.ac.cn

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：

中国浙江省温州市鹿城区学院西路274号

研究负责人通讯地址：

中国浙江省温州市鹿城区学院西路274号

Applicant address：

No. 274, Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang, China

Study leader's address：

No. 274, Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang, 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：

温州医科大学附属眼视光医院

Applicant's institution：

Wenzhou Medical University Affiliated Eye Hospital

研究负责人所在单位：

温州医科大学附属眼视光医院

Affiliation of the Leader：

Wenzhou Medical University Affiliated Eye 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：

 温医大眼视光伦审2024研第142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：

温州医科大学附属眼视光医院伦理委员会

Name of the ethic committee：

Ethics Committee of Wenzhou Medical University Affiliated Eye and Vision Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-30 00:00:00

伦理委员会联系人：

谷佩秋

Contact Name of the ethic committee：

Gu Peiqiu

伦理委员会联系地址：

中国浙江省温州市鹿城区学院西路274号

Contact Address of the ethic committee：

No. 274, Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 136 9589 6445

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 EYE_ec@126.com

研究实施负责（组长）单位：

温州医科大学附属眼视光医院

Primary sponsor：

Wenzhou Medical University Affiliated Eye Hospital

研究实施负责（组长）单位地址：

中国浙江省温州市鹿城区学院西路274号

Primary sponsor's address：

No. 274, Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang, 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)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属眼视光医院

具体地址：

中国浙江省温州市鹿城区学院西路274号

Institution
hospital：

Wenzhou Medical University Affiliated Eye Hospital

Address：

No. 274, Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang, China

经费或物资来源：

研究者自筹经费

Source(s) of funding：

Researchers raise their own funds

研究疾病：

斜视  

Target disease：

Strabismus

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：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：观察氢吗啡酮联合吸入麻醉在小儿斜弱视手术拔管后，取得较好的镇静、镇痛效果。 次要目的：观察氢吗啡酮联合吸入麻醉在小儿斜视手术中应用后是否会影响术后拔管效率。  

Objectives of Study：

Main objective: To observe the good sedative and analgesic effects of hydromorphone combined with inhalation anesthesia after extubation in pediatric amblyopia surgery. Secondary objective: To observe whether the use of hydromorphone combined with inhalation anesthesia in pediatric strabismus surgery affects postoperative extubation efficiency.

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. 3-6岁拟行斜视手术，并进行全身麻醉的学龄前儿童。 2. ASA评分1级。 3. BMI范围为15-18。 4. 没有在试验前或过程中使用镇静镇痛药物。 5. 在诊室间术前检查时，患者术前自愿入组。

Inclusion criteria

1. Preschool children aged 3-6 who plan to undergo strabismus surgery and receive general anesthesia. 2. ASA rating is level 1. 3. The BMI range is 15-18. 4. No sedative or analgesic drugs were used before or during the experiment. 5. During the preoperative examination in the consultation room, patients voluntarily enrolled before surgery.

排除标准：

1.心脏，肺部，肝肾功能或内分泌功能异常的患者。 2. 对氢吗啡酮或七氟烷相应成分过敏的患者。 3. 家族有恶心高热病史；有精神疾病史的患者。

Exclusion criteria：

1. Patients with abnormal heart, lung, liver and kidney function or endocrine function. 2. Patients who are allergic to the corresponding components of hydromorphone or sevoflurane. 3. Family history of nausea and high fever; Patients with a history of mental illness.

研究实施时间：

Study execute time：

从 From 2025-01-09 00:00:00至 To 2025-03-26 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-09 00:00:00 至 To 2025-03-26 00:00:00

干预措施：

Interventions：

组别：

氢吗啡酮组

样本量：

 39

Group：

Hydromorphone group

Sample size：

干预措施：

取得患者知情同意情况下，所有患者术前8h开始禁食，术前2h开始禁饮，行七氟烷吸入的全身麻醉。试验组麻醉诱导使用氢吗啡酮0.02mg/kg，丙泊酚3mg/kg，米库氯铵0.1mg/kg，阿托品0.01mg/kg。静脉诱导后进行喉罩置入，8-10ml/kg 潮气量进行机械通气，调节呼吸频率维持呼吸末二氧化碳在36-40mmHg。术中用七氟烷和10ug/kg/h瑞芬太尼维持儿童BIS值在40-60。手术进行到缝结膜阶段时，停瑞芬太尼，改小七氟烷浓度至0.5MAC，准备缝合最后一个结膜口时停七氟烷吸入。进行清洁包扎时，加大新鲜气体流量，洗出残余的七氟烷。送入恢复室后在有自主呼吸时深麻醉下拔管继续观察，观察评估术后10min，2h，24h患儿疼痛评分，躁动情况。

干预措施代码：

Intervention：

With the informed consent of the patients, all patients began fasting 8 hours before surgery and drinking 2 hours before surgery, and underwent general anesthesia with inhalation of sevoflurane. The experimental group received anesthesia induction with 0.02mg/kg of hydromorphone, 3mg/kg of propofol, 0.1mg/kg of miconazole, and 0.01mg/kg of atropine. After intravenous induction, laryngeal mask insertion was performed, and mechanical ventilation was performed with a tidal volume of 8-10ml/kg. The respiratory rate was adjusted to maintain end tidal carbon dioxide at 36-40mmHg. During the operation, sevoflurane and 10ug/kg/h remifentanil were used to maintain the BIS value of children at 40-60. When the surgery reaches the stage of suturing the conjunctiva, stop remifentanil and reduce the concentration of sevoflurane to 0.5MAC. Stop inhaling sevoflurane when preparing to suture the last conjunctival opening. When cleaning and bandaging, increase the flow of fresh gas to wash out residual sevoflurane. After being sent to the recovery room, under deep anesthesia with spontaneous breathing, the tube was removed and continued to be observed. Pain scores and agitation were evaluated at 10 minutes, 2 hours, and 24 hours after surgery.

Intervention code：

组别：

芬太尼组

样本量：

 39

Group：

Fentanyl group

Sample size：

干预措施：

取得患者知情同意情况下，所有患者术前8h开始禁食，术前2h开始禁饮，行七氟烷吸入的全身麻醉。试验组麻醉诱导使用芬太尼1ug/kg，丙泊酚3mg/kg，米库氯铵0.1mg/kg，阿托品0.01mg/kg。静脉诱导后进行喉罩置入，8-10ml/kg 潮气量进行机械通气，调节呼吸频率维持呼吸末二氧化碳在36-40mmHg。术中用七氟烷和10ug/kg/h瑞芬太尼维持儿童BIS值在40-60。手术进行到缝结膜阶段时，停瑞芬太尼，改小七氟烷浓度至0.5MAC，准备缝合最后一个结膜口时停七氟烷吸入。进行清洁包扎时，加大新鲜气体流量，洗出残余的七氟烷。送入恢复室后在有自主呼吸时深麻醉下拔管继续观察，观察评估术后10min，2h，24h患儿疼痛评分，躁动情况。

干预措施代码：

Intervention：

With the informed consent of the patients, all patients began fasting 8 hours before surgery and drinking 2 hours before surgery, and underwent general anesthesia with inhalation of sevoflurane. The experimental group received anesthesia induction with fentanyl at a dose of 1ug/kg, propofol at a dose of 3mg/kg, miconazole at a dose of 0.1mg/kg, and atropine at a dose of 0.01mg/kg. After intravenous induction, laryngeal mask insertion was performed, and mechanical ventilation was performed with a tidal volume of 8-10ml/kg. The respiratory rate was adjusted to maintain end tidal carbon dioxide at 36-40mmHg. During the operation, sevoflurane and 10ug/kg/h remifentanil were used to maintain the BIS value of children at 40-60. When the surgery reaches the stage of suturing the conjunctiva, stop remifentanil and reduce the concentration of sevoflurane to 0.5MAC. Stop inhaling sevoflurane when preparing to suture the last conjunctival opening. When cleaning and bandaging, increase the flow of fresh gas to wash out residual sevoflurane. After being sent to the recovery room, under deep anesthesia with spontaneous breathing, the tube was removed and continued to be observed. Pain scores and agitation were evaluated at 10 minutes, 2 hours, and 24 hours after surgery.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 温州医科大学附属眼视光医院 

单位级别：

 三甲 

Institution
hospital：

Wenzhou Medical University Affiliated Eye Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

患儿术后躁动评分

指标类型：

主要指标

Outcome：

Postoperative agitation score for pediatric patients

Type：

Primary indicator

测量时间点：

术后10min，2h，24h

测量方法：

RASS评分量表

Measure time point of outcome：

Postoperative 10 minutes, 2 hours, and 24 hours

Measure method：

RASS Rating Scale

指标中文名：

患儿术后疼痛评分

指标类型：

次要指标

Outcome：

Postoperative pain score for pediatric patients

Type：

Secondary indicator

测量时间点：

术后10min，2h，24h

测量方法：

评分量表

Measure time point of outcome：

Postoperative 10 minutes, 2 hours, and 24 hours

Measure method：

Rating scale

指标中文名：

患儿术后拔管时间

指标类型：

副作用指标

Outcome：

Postoperative extubation time for pediatric patients

Type：

Adverse events

测量时间点：

拔出气管导管的时间点

测量方法：

记录

Measure time point of outcome：

Time point for pulling out the tracheal tube

Measure method：

Record

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age 6 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）：

参与研究后，患者被随机分为两组（氢吗啡酮组和芬太尼组）。随机化是使用计算机生成的数字进行的，然后密封在信封中。 手术前，一名不知道研究细节的护士随机打开一个密封的信封，将患者分为对照组或干预组。由麻醉师进行相应的分组手术。患者组的结果评估员不知道随机结果的评估和记录。

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

After participating in the study, patients were randomly divided into two groups (hydromorphone group and fentanyl group). Randomization is performed using computer-generated numbers and then sealed in an envelope. Before the surgery, a nurse who was unaware of the research details randomly opened a sealed envelope and assigned patients to either a control group or an intervention group. Perform the corresponding group operations by anesthesiologists. The outcome assessors of the patient group are not aware of the evaluation and recording of the randomized results.

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：

本研究采用双盲设计。受试者、研究者（包括干预实施者、疗效评估者）均不知分组情况。试验组与对照组的分组由计算机生成的随机二维码分配。仅在发生严重不良事件需医疗干预时，经主要研究者批准后可揭盲。

Blinding：

This study adopts a double-blind design. The subjects and researchers (including intervention implementers and efficacy evaluators) are not aware of the grouping situation. The grouping of the experimental group and the control group was assigned by a computer-generated random QR code. Only when serious adverse events require medical intervention, unblinding can be performed with the approval of the principal investigator.

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）：

原始研究数据可在网络平台ResMan（http://www.medresman.org.cn/）上获取，在试验结束6个月内上传试验数据。

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

Original research data in the network platform ResMan (http://www.medresman.org.cn/), a period of 6 months at the end of the test to upload the test data.

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：

数据采集工具：采用病例记录表（CRF）和ResMan电子数据采集系统（EDC）。CRF依据研究方案设计，包含基线、疗效和安全性指标。EDC系统符合21 CFR Part 11规范，支持审计追踪与角色权限管理。 数据录入：研究者根据源文件在EDC中录入数据，72小时内完成并双人核对。系统自动触发逻辑校验，异常数据生成疑问表由研究者在线修订。 数据质控：独立数据管理员定期核查数据一致性，监查员进行现场源数据验证（SDV）。数据库锁定前，所有疑问需解决并经盲态审核。"

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

Data collection tools: Case Record Form (CRF) and ResMan Electronic Data Collection System (EDC) were used. CRF is designed according to the research protocol, including baseline, efficacy, and safety indicators. The EDC system complies with the 21 CFR Part 11 standard and supports audit tracking and role permission management. Data entry: Researchers enter data into EDC based on source files and complete and double check within 72 hours. The system automatically triggers logical verification, and the question table generated from abnormal data is revised online by the researcher. Data quality control: Independent data administrators regularly verify data consistency, while monitors conduct on-site source data validation (SDV). Before locking the database, all questions must be resolved and undergo blind review. "

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：

  2025-11-24 16:04:36