ChiCTR2500107412 版本V1.0 版本创建时间2025/08/11 15:07:26 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：

 ChiCTR2500107412 

最近更新日期：

Date of Last Refreshed on：

 2025-08-11 15:07:09 

注册时间：

Date of Registration：

 2025-08-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

右美托咪定联合艾司氯胺酮术前滴鼻在扁桃体切除术儿童的应用研究

Public title：

Study on the application of dexmedetomidine combined with Esketamine nasal drops before tonsillectomy in children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

右美托咪定联合艾司氯胺酮术前滴鼻在扁桃体切除术儿童的应用研究

Scientific title：

Study on the application of dexmedetomidine combined with Esketamine nasal drops before tonsillectomy in children

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：

毛卫亮 

研究负责人：

毛卫亮 

Applicant：

Mao Weiliang 

Study leader：

Mao Weiliang 

申请注册联系人电话：

Applicant telephone：

 +86 159 0672 8970

研究负责人电话：

Study leader's
telephone：

+86 159 0672 8970

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：

 1554159820@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1554159820@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：

浙江省湖州市广场后路158号

研究负责人通讯地址：

浙江省湖州市广场后路158号

Applicant address：

No. 158, Square Back Road, Huzhou, Zhejiang

Study leader's address：

No. 158, Square Back Road, Huzhou, Zhejiang

申请注册联系人邮政编码：

Applicant postcode：

 313000

研究负责人邮政编码：

Study leader's postcode：

 313000

申请人所在单位：

湖州市第一人民医院

Applicant's institution：

Huzhou First People's Hospital

研究负责人所在单位：

湖州市第一人民医院

Affiliation of the Leader：

Huzhou First 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：

 伦审第(2023KYLL048-01)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：

湖州市第??民医院医学科研与临床试验伦理委员会

Name of the ethic committee：

Medical Research and Clinical Trial Ethics Committee of Huzhou First People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-23 00:00:00

伦理委员会联系人：

彭雪花

Contact Name of the ethic committee：

Peng Xuehua

伦理委员会联系地址：

浙江省湖州市广场后路158号

Contact Address of the ethic committee：

No. 158, Square Back Road, Huzhou, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 572 213 0509

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hzyyllwyh@163.com

研究实施负责（组长）单位：

湖州市第一人民医院

Primary sponsor：

Huzhou First People's Hospital

研究实施负责（组长）单位地址：

浙江省湖州市广场后路158号

Primary sponsor's address：

No. 158, Square Back Road, Huzhou, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

湖州市

Country：

China

Province：

Zhejiang

City：

Huzhou

单位(医院)：

湖州市第一人民医院

具体地址：

浙江省湖州市广场后路158号

Institution
hospital：

Huzhou First People's Hospital

Address：

No. 158, Square Back Road, Huzhou, Zhejiang

经费或物资来源：

自筹5万

Source(s) of funding：

Apply to the science and technology department for 50000 yuan and raise 50000 yuan

研究疾病：

扁桃体炎  

Target disease：

amygdalitis

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1通过序贯法确定艾司氯胺酮及右美托咪定术前滴鼻最佳配伍剂量 2探究右美托咪定联合艾司氯胺酮滴鼻对扁桃体切除术儿童镇静疗效，术前血流动力学及不良反应的影响 3探究右美托咪定联合艾司氯胺酮滴鼻对扁桃体切除术儿童血流动力学及苏醒质量的影响  

Objectives of Study：

1. Determine the best compatible dose of exketamine and dexmedetomidine nasal drops before operation by sequential method To explore the effects of dexmedetomidine combined with esketamine nasal drops on sedative efficacy, preoperative hemodynamics and adverse reactions in children undergoing tonsillectomy To explore the effect of dexmedetomidine combined with esketamine nasal drops on hemodynamics and recovery quality in children undergoing tonsillectomy

药物成份或治疗方案详述：

第一部分：患儿禁食4～8h,禁水2～3h。术前30～40 min由家长陪同进入手术等候间。40名小儿鼻内滴入右美托咪定（批号：h32732931，江苏恒瑞医药股份有限公司），在右美托咪定2ug/kg滴鼻的基础上，起始剂量给予艾司氯胺酮（批号：2362384BL，江苏恒瑞医药股份有限公司）2mg/kg滴鼻，并进行指脉搏氧饱和度监测，观察30分钟，采用威斯康星州儿童医院镇静量表评分（Wisconsin children's Hospital sedation scale score，CHW）进行评分，CHW评分≤3分即镇静成功。若镇静成功，将下个受试者艾司氯胺酮滴鼻剂量下调一个梯度（0.10mg/kg），若镇静失败则立即追加艾司氯胺酮0.5mg/kg滴鼻，并将下个受试者右美托咪定滴鼻剂量上调一个梯度（0.10mg/kg）。若患者给药后出现呼吸抑制，过敏，氧饱和度下降等不良反应，及时给予积极对症处理。采用Probit分析法计算联合右美托咪定滴鼻时艾司氯胺酮的ED50%,ED95%及95%CI，采用GraphPad Prism 5制作拟合量效应曲线。双侧检验，检验水准α=0.05。 第二部分：患儿禁食4～8h,禁水2～3h。术前30～40 min由家长陪同进入手术等候间。采用随机数字表法将患儿分为2组：右美托咪定滴鼻组（对照组）：鼻内滴入右美托咪定3μg/kg；右美托咪定复合艾司氯胺酮滴鼻组（观察组）：鼻内滴入右美托咪定2μg/kg、以及第一部分研究中艾司氯胺酮ED95%剂量。患儿取仰卧位，清洁鼻腔，使用1ml注射器将镇静药物均匀滴入两侧鼻孔，并用手指轻捏促进吸收。使用便携式监测仪连续监测血压、SpO2和HR（迈瑞监护仪），直至患儿进入手术室。于给药前和给药后每5min，麻醉医生采用CHW评分进行镇静评估。于给药前和给药后30min时记录CHW评分、SpO2和HR，计算给药后SpO2，HR下降率。记录镇静起效时间[从鼻内给予镇静药物即刻至达到满意镇静（CHW评分≤3影响），镇静过程中恶心呕吐、心动过缓、呼吸抑制等不良反应发生情况。 第三部分：患者入室后以PhillpsMP20监护仪常规监测血压(BP)、心率(HR)、心电图(ECG)、氧饱和度(SPO2)以及脑电双频谱指数（Bispectralindex，BIS）。全身麻醉诱导：采用静脉注射丙泊酚1～2.0mg/kg，芬太尼5μg/kg和顺式阿曲库铵0.15mg/kg。待患儿意识丧失后气管插管行机械通气：设置潮气量（tida1 vo1ume,VT）为6～10mL/kg,RR12～20次/min,维持呼气末二氧化碳分压(end-expiratory carbon dioxide partialpressure,PET-CO2)在35～45 mmHg(1 mmHg=0.133kPa）。麻醉维持：术中持续吸入2%～3%七氟烷维持麻醉，将BIS值控制在45~60。术毕停止吸入七氟烷，待患儿自主呼吸、意识恢复后拔除气管插管。继续给予面罩吸氧，待患儿生命体征平稳后将其转移到麻醉后恢复室。记录患儿麻醉前（T0）、插管时（T1）、插管后5min（T2）、拔管时（T3）、拔管后5 min（T4）、10min（T5）的心率（HR）和平均动脉压（MAP）以及手术时间、苏醒时间、PACU停留时间(进入PACU至改良Aldrete恢复评分≥9分[12])和术后不良反应发生情况。采用小儿麻醉苏醒躁动评分量表（pediatric anesthesia emergence delirium,PAED）、FUNK神经行为评分、和疼痛行为评分量表（Face, legs, activity, cry, consolability,FLACC）对患儿进入麻醉后恢复室后30min内的躁动发生及疼痛情况进行评分。 

Description for medicine or protocol of treatment in detail：

History of systemic diseases (congenital heart disease, asthma or central nervous system disease, etc.), abnormal liver and kidney function, drug or food allergy history, abnormal nasal structure; Have a history of upper respiratory tract infection in the past two weeks and have used Dex, etc. one month before operation α 2 Receptor agonists and other drugs that affect the test results. Part I: The children were fasting for 4 to 8 hours and water for 2 to 3 hours. 30 to 40 minutes before the operation, the patient was accompanied by his parents to enter the waiting room. 40 children were intranasal drip of dexmedetomidine (batch number: h32732931, Jiangsu Hengrui Pharmaceutical Co., Ltd.). On the basis of intranasal drip of dexmedetomidine 2ug/kg, the initial dose was given with Esketamine (batch number: 2362384BL, Jiangsu Hengrui Pharmaceutical Co., Ltd.) 2mg/kg nasal drip, and the finger pulse oxygen saturation was monitored for 30 minutes, The Wisconsin children's Hospital sedation scale score (CHW) was used for scoring. The score of CHW <= 3 was successful sedation. If sedation is successful, reduce the nasal dose of Esketamine for the next subject by a gradient (0.10 mg/kg). If sedation fails, immediately add 0.5 mg/kg of Esketamine for nasal drops, and increase the nasal dose of dexmedetomidine for the next subject by a gradient (0.10 mg/kg). If the patient has respiratory depression, allergy, oxygen saturation reduction and other adverse reactions after administration, timely give active symptomatic treatment. Probit analysis method was used to calculate the ED50%, ED95% and 95% CI of Esketamine when combined with dexmedetomidine nasal drops. GraphPad Prism 5 was used to make the fitting dose-effect curve. Bilateral inspection α= 0.05 The second part: The children were fasting for 4 to 8 hours and water for 2 to 3 hours. 30 to 40 minutes before the operation, the patient was accompanied by his parents to enter the waiting room. The children were divided into two groups by random number table: dextrometomidine nasal drip group (control group): dextrometomidine nasal drip 3 μ g/kg; Dextrmetomidine combined with Esketamine nasal drip group (observation group): Dextrmetomidine 2 was intranasal drip μ G/kg, and 95% dose of Esketamine ED. The child should take a supine position, clean the nasal cavity, use a 1ml syringe to evenly drop sedative drugs into both nostrils, and gently pinch with fingers to promote absorption. Use a portable monitor to continuously monitor blood pressure, SpO2 and HR (Mindray monitor) until the child enters the operating room. Before and every 5min after administration, anesthesiologists used CHW score to evaluate sedation. Record the CHW score, SpO2 and HR before and 30 minutes after administration, and calculate the decline rate of SpO2 and HR after administration. Record the onset time of sedation [from the instant of intranasal administration of sedative drugs to the satisfaction of sedation (CHW score ≤ 3), and the occurrence of nausea, vomiting, bradycardia, respiratory depression and other adverse reactions during sedation. The third part: After the patient enters the room, the blood pressure (BP), heart rate (HR), electrocardiogram (ECG), oxygen saturation (SPO2) and bispectral index (BIS) of EEG were routinely monitored with the PhillipsMP20 monitor. General anesthesia induction: propofol 1 ~ 2.0mg/kg, fentanyl 5 μ G/kg and cis atracurium 0.15 mg/kg. After the child loses consciousness, intubate the trachea for mechanical ventilation: set the tidal volume (VT) at 6-10mL/kg, RR12-20 times/min, and maintain the end-expiratory carbon dioxide partial pressure (PET-CO2) at 35-45 mmHg (1 mmHg=0.133kPa). Anesthesia maintenance: continue to inhale 2%~3% sevoflurane during operation to maintain anesthesia, and control the BIS value at 45~60. Inhalation of sevoflurane was stopped after operation, and tracheal intubation was removed after the child's spontaneous breathing and consciousness recovered. Continue to give oxygen to the mask, and transfer the child to the post-anesthesia recovery room after his vital signs are stable. Record the heart rate (HR) and mean arterial pressure (MAP) of the child before anesthesia (T0), at intubation (T1), 5 minutes after intubation (T2), at extubation (T3), 5 minutes after extubation (T4), and 10 minutes after extubation (T5), as well as the operation time, awakening time, PACU retention time (from entering PACU to improved Aldrote recovery score ≥ 9 points [12]) and the occurrence of adverse reactions after operation. Pediatric anesthesia emergency delirium (PAED), FUNK neurobehavioral score, and pain behavior score (Face, legs, activity, cry, stability, FLACC) were used to score the occurrence of restlessness and pain within 30 minutes after entering the recovery room after anesthesia. 

纳入标准：

ASA分级I～II级；于我院行扁桃体切除术；年龄 3~ 7 岁，体重 10~30 kg(BMI 13~24 kg/m^2)；心电图提示无异常，阿托品试验阴性；术前无贫血以及代谢紊乱（包括水、电解质、酸碱平衡紊乱）；

Inclusion criteria

ASA grade I to II; Tonsillectomy was performed in our hospital; Age 3~7 years old, weight 10~30 kg (BMI 13~24 kg/m^2); ECG showed no abnormality and atropine test was negative; There was no anemia and metabolic disorder (including water, electrolyte, acid-base balance disorder) before operation;

排除标准：

系统性疾病史(先天性心脏病、哮喘或中枢神经系 统疾病等)，肝肾功能异常，药物或食物过敏史，鼻部结构异常；近 2 周有上呼吸道感染病史及术前 1 月使用过 Dex 等 α2 受体激动药及其他影响试验结果的药物。

Exclusion criteria：

History of systemic diseases (congenital heart disease, asthma or central nervous system disease, etc.), abnormal liver and kidney function, drug or food allergy history, abnormal nasal structure; Have a history of upper respiratory tract infection in the past two weeks and have used Dex, etc. one month before operation α 2 Receptor agonists and other drugs that affect the test results.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-29 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

序贯试验组

样本量：

 40

Group：

Sequential test group

Sample size：

干预措施：

第一部分：通过改良Dixon序贯法确定艾司氯胺酮与右美托咪定术前滴鼻最佳配伍剂量

干预措施代码：

Intervention：

The first part: to determine the optimal nasal compatible dose of esmketamine and dexmedetomidine by modified Dixon sequential method

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control group

Sample size：

干预措施：

鼻内滴入右美托咪定3μg/kg

干预措施代码：

Intervention：

Intranasal drip of dexmedetomidine 3 μ g/kg

Intervention code：

组别：

观察组

样本量：

 30

Group：

Observation group

Sample size：

干预措施：

鼻内滴入右美托咪定2μg/kg、以及第一部分研究中艾司氯胺酮ED95%药剂

干预措施代码：

Intervention：

Intranasal drip of dexmedetomidine 2 μ G/kg, and 95% of Esketamine ED

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 湖州市 

Country：

China

Province：

Zhejiang

City：

Huzhou

单位(医院)：

 湖州市第一人民医院 

单位级别：

 三甲医院 

Institution
hospital：

Huzhou First People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血压

指标类型：

主要指标

Outcome：

blood pressure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

氧饱和度

指标类型：

主要指标

Outcome：

SpO2

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

指标类型：

主要指标

Outcome：

heart rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

威斯康星州儿童医院镇静量表评分

指标类型：

主要指标

Outcome：

Wisconsin children's Hospital sedation scale score，CHW评分

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Operation 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：

苏醒时间

指标类型：

主要指标

Outcome：

Awakening time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

恢复室停留时间

指标类型：

主要指标

Outcome：

PACU dwell time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后不良反应

指标类型：

次要指标

Outcome：

Postoperative adverse reactions

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

小儿麻醉苏醒躁动评分量表

指标类型：

主要指标

Outcome：

pediatric anesthesia emergence delirium,PAED

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛行为评分量表

指标类型：

次要指标

Outcome：

Face, legs, activity, cry, consolability,FLACC

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

FUNK神经行为评分

指标类型：

主要指标

Outcome：

FUNK neurobehavioral score

Type：

Primary 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：

无

Sample Name：

none

Tissue：

none

人体标本去向

 使用后销毁  

说明

无

Fate of sample：

Destruction after use  

Note：

none

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age 7 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）：

本研究人员采用随机数字表法产生

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

The researchers used random number table method to generate

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：

单盲，对受试者设盲。

Blinding：

Single blind, blinding the subjects.

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）：

研究公开发表后半年，邮件联系研究负责人合理获取。

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

Six months after the publication of the research, contact the research leader via email to obtain reasonable information.

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：

1.1 研究数据来源 数据将通过以下方式收集： 儿童患者的基础信息，包括性别、年龄、体重、ASA分级等，通过病历记录。 手术过程相关数据，包括术前用药剂量、用药时间、麻醉维持时间和手术时长，通过麻醉记录单记录。 生理指标数据：心率、血压、血氧饱和度等，通过监护仪自动采集并记录。 术后恢复情况：疼痛评分（如FLACC评分）、苏醒时间、术后恶心呕吐（PONV）发生率等，通过标准化观察和患者家属反馈表记录。 1.2 数据采集工具 使用标准化的纸质数据采集表（CRF表）或电子数据采集系统（EDC），如Medidata或REDCap，以保证数据的完整性和一致性。 2.1 数据输入和审核 所有数据将由研究助理负责初步录入CRF表，并在录入后的48小时内由独立数据管理员审核和验证。 2.2 数据清理 数据清理由数据管理员按照预先制定的规则进行，识别并处理以下问题： 缺失值（使用“NA”标注并备注原因）。 数据错误（如非合理值的及时核实）。 重复数据（定期检查和去重）。 2.3 数据编码 使用标准化编码系统（如MedDRA或WHO-DD）对不良反应及药物信息进行统一编码，以确保数据的规范性和国际可比性。

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

1.1 Research Data Sources The data will be collected through the following methods: Basic information of pediatric patients, including gender, age, weight, ASA grading, etc., is recorded through medical records. Surgical process related data, including preoperative medication dosage, medication duration, anesthesia maintenance time, and surgical duration, are recorded through anesthesia record sheets. Physiological indicators data: heart rate, blood pressure, blood oxygen saturation, etc., are automatically collected and recorded through a monitor. Postoperative recovery status: Pain score (such as FLACC score), recovery time, incidence of postoperative nausea and vomiting (PONV), etc., recorded through standardized observation and patient family feedback forms. 1.2 Data Collection Tools Use standardized paper data collection forms (CRF forms) or electronic data collection systems (EDC) such as Medidata or REDCap to ensure data integrity and consistency. 2.1 Data Input and Review All data will be initially entered into the CRF form by the research assistant and reviewed and validated by an independent data administrator within 48 hours of entry. 2.2 Data Cleaning Data cleaning is carried out by data administrators according to predetermined rules, identifying and addressing the following issues: Missing values (marked with "NA" and reasons noted). Data errors (such as timely verification of unreasonable values). Duplicate data (regularly checked and deduplicated). 2.3 Data Encoding Use standardized coding systems (such as MedDRA or WHO-DD) to unify the coding of adverse reactions and drug information to ensure the standardization and international comparability of data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-08-11 15:07:09