ChiCTR2500107385 版本V1.0 版本创建时间2025/08/11 09:47:20 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：

 ChiCTR2500107385 

最近更新日期：

Date of Last Refreshed on：

 2025-08-11 09:46:54 

注册时间：

Date of Registration：

 2025-08-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

分娩后小剂量艾司氯胺酮对孕期抑郁症状干预效果的临床评价：一项前瞻性随机对照研究

Public title：

Clinical Evaluation of the Effect of Low-dose Esketamine on Perinatal Depression Symptoms after Delivery: A Prospective Randomized Controlled Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

分娩后小剂量艾司氯胺酮对孕期抑郁症状干预效果的临床评价：一项前瞻性随机对照研究

Scientific title：

Clinical Evaluation of the Effect of Low-dose Esketamine on Perinatal Depression Symptoms after Delivery: A Prospective Randomized Controlled Study

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：

曾彩华 

研究负责人：

曾彩华 

Applicant：

Caihua Zeng 

Study leader：

Caihua Zeng 

申请注册联系人电话：

Applicant telephone：

 +86 138 2712 4022

研究负责人电话：

Study leader's
telephone：

+86 138 2712 4022

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：

 1395047887@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1395047887@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：

广东省湛江市霞山区汇泉盛景名苑9栋

研究负责人通讯地址：

广东省湛江市霞山区汇泉盛景名苑9栋

Applicant address：

Building 9, Huiquanshengjing Mingyuan, Xiashan District, Zhanjiang City, Guangdong Province

Study leader's address：

Building 9, Huiquanshengjing Mingyuan, Xiashan District, Zhanjiang 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：

广东医科大学附属第二医院

Applicant's institution：

The Second Affiliated Hospital of Guangdong Medical University

研究负责人所在单位：

广东医科大学附属第二医院

Affiliation of the Leader：

The Second Affiliated Hospital of Guangdong Medical University

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：

 PJKT2025-080

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：

广东医科大学附属第二医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Guangdong Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-30 00:00:00

伦理委员会联系人：

陈元

Contact Name of the ethic committee：

Yuan Chen

伦理委员会联系地址：

广东医科大学附属第二医院3号住院楼11楼空中花园医学伦理办公室

Contact Address of the ethic committee：

Medical Ethics Office, 11th Floor, Sky Garden, No. 3 Inpatient Building, the Second Affiliated Hospital of Guangdong Medical University

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 759 237 2359

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：

广东医科大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Guangdong Medical University

研究实施负责（组长）单位地址：

广东省湛江市霞山区民有路12号

Primary sponsor's address：

No. 12, Minyou Road, Xiashan District, Zhanjiang 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)：

湛江市

Country：

China

Province：

Guangdong

City：

Zhanjiang

单位(医院)：

广东医科大学附属第二医院

具体地址：

广东省湛江市霞山区民有路12号

Institution
hospital：

The Second Affiliated Hospital of Guangdong Medical University

Address：

No. 12, Minyou Road, Xiashan District, Zhanjiang City, Guangdong Province

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

妊娠晚期入院准备分娩、且EPDS评分≥10分，拟择期行剖宫产手术的孕妇  

Target disease：

Pregnant women who are admitted to the hospital in the third trimester for delivery preparation, have an EPDS score of ≥10 points, and are scheduled for elective cesarean section.

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在探索一种更优的产后抑郁干预策略，具体目标包括： I：临床干预目的：通过构建“分娩后一次性静脉注射+术后PCA持续输注小剂量艾司氯胺酮”的联合给药模式，评估其对产后早期抑郁症状的缓解效果，明确其干预的时效性和持续性。 II：剂量与安全性优化：比较联合干预组与传统PCA镇痛组在镇痛效果、艾司氯胺酮使用总量及不良反应发生率方面的差异，探索在保障镇痛效果的前提下，降低药物浓度与用量的可能性。 III：建立可推广的干预方案：在现有麻醉镇痛流程中嵌入情绪干预策略，初步验证该方案的临床可行性与推广价值，促进围产期心理健康管理的整合发展。  

Objectives of Study：

This study aims to explore a more effective intervention strategy for postpartum depression, with specific goals including: Objective of clinical intervention: By establishing a combined drug administration model of "one-time intravenous injection after delivery + continuous infusion of low-dose esketamine via patient-controlled analgesia (PCA) after surgery", to evaluate its effect on alleviating early postpartum depressive symptoms, and to clarify the timeliness and sustainability of the intervention. II: Dose and Safety Optimization: Compare the differences in analgesic effect, total dosage of esketamine used, and incidence of adverse reactions between the combined intervention group and the traditional PCA analgesia group, and explore the possibility of reducing drug concentration and dosage while ensuring analgesic effect. III: Establishing a Promotable Intervention Program: Embedding emotional intervention strategies into the existing anesthesia and analgesia process, initially verifying the clinical feasibility and promotional value of this program, and promoting the integrated development of perinatal mental health management.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

年龄 ≥18 岁，具备完全民事行为能力，能够理解并签署知情同意书；择期剖宫产的产妇；妊娠晚期（孕周 ≥37 周）入院待产者；入院时 Edinburgh 产后抑郁量表（EPDS）评分 ≥10 分，提示存在产前抑郁症状；ASA（美国麻醉医师学会）分级评估为 I–II 级，能接受术后PCA镇痛管理；同意参与本研究并签署书面知情同意书。

Inclusion criteria

Aged >=18 years old, with full capacity for civil conduct, capable of understanding and signing the informed consent form; women undergoing elective cesarean section; admitted to the hospital in the late stage of pregnancy (gestational age ≥37 weeks) for labor; with a score of ≥10 on the Edinburgh Postnatal Depression Scale (EPDS) at admission, indicating the presence of prenatal depression symptoms; with an ASA (American Society of Anesthesiologists) classification of I-II, able to accept postoperative PCA analgesia management; agree to participate in this study and sign a written informed consent form.

排除标准：

既往明确精神疾病诊断史（如重度抑郁症、精神分裂症、双相障碍等）；正在服用抗抑郁药、抗精神病药或其他影响中枢神经系统的药物；存在妊娠期严重并发症（如重度子痫前期、胎盘早剥、HELLP综合征等）；对氯胺酮或舒芬太尼等麻醉镇痛药物过敏，或存在相关禁忌症；合并严重心、肝、肾功能障碍或癫痫病史；ASA分级 ≥III 级，不宜接受术后PCA镇痛治疗者；有药物滥用史或其他可能干扰研究结果判断的行为；不愿配合研究或预期无法完成研究随访者。

Exclusion criteria：

A clear history of mental illness diagnosis in the past (such as major depressive disorder, schizophrenia, bipolar disorder, etc.); currently taking antidepressants, antipsychotics or other drugs that affect the central nervous system; having severe complications during pregnancy (such as severe preeclampsia, placental abruption, HELLP syndrome, etc.); allergic to ketamine or sufentanil and other anesthetic analgesic drugs, or having related contraindications; having severe heart, liver, kidney function disorders or a history of epilepsy; ASA classification >= III, not suitable for postoperative PCA analgesia treatment; having a history of drug abuse or other behaviors that may interfere with the judgment of research results; unwilling to cooperate with the research or expected to be unable to complete the research follow-up.

研究实施时间：

Study execute time：

从 From 2025-08-08 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-15 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：

艾司氯胺酮组

样本量：

 40

Group：

The Esketamine Group

Sample size：

干预措施：

待胎儿取出剪断脐带后，通过建立的静脉留置针通道注射配制好的0.2mg/kg 的艾司氯胺酮5 ml，剖宫产手术结束后留置镇痛泵，镇痛药物使用艾司氯胺酮 1mg/kg+舒芬太尼100ug+昂丹司琼 16mg，配制总容量为 100ml。

干预措施代码：

Intervention：

After the fetus is delivered and the umbilical cord is cut, 5 ml of 0.2 mg/kg esketamine is injected through the established intravenous indwelling needle channel. After the cesarean section is completed, an analgesic pump is left in place. The analgesic drugs used are 1 mg/kg esketamine + 100 μg sufentanil + 16 mg ondansetron, with a total volume of 100 ml.

Intervention code：

组别：

生理盐水组

样本量：

 40

Group：

The Normal Saline Group

Sample size：

干预措施：

待胎儿取出剪断脐带后，通过静脉通道静脉注射 0.9%氯化钠注射液5ml，剖宫产手术结束后留置镇痛泵，镇痛药物使用舒芬太尼150ug+昂丹司琼 8mg，配制总容量为 100ml。

干预措施代码：

Intervention：

After the fetus is removed and the umbilical cord is cut, 5 ml of 0.9% sodium chloride injection is administered intravenously through the venous access. After the cesarean section is completed, a pain pump is retained. The analgesic drugs used are sufentanil 150 μg and ondansetron 8 mg, with a total volume of 100 ml.

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)：

 湛江市 

Country：

China

Province：

Guangdong

City：

Zhanjiang

单位(医院)：

 广东医科大学附属第二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Guangdong Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

产后30天EPDS评分改善率

指标类型：

主要指标

Outcome：

The improvement rate of EPDS score within 30 days postpartum

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应发生情况：恶心、呕吐、眩晕、呼吸抑制、精神副作用等。

指标类型：

次要指标

Outcome：

Adverse reactions: nausea, vomiting, dizziness, respiratory depression, mental side effects, etc.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

镇痛效果与阿片类药物总用量：术后6h、24h、48h进行VAS/NRS镇痛评分，同时记录镇痛期间阿片类药物总用量。

指标类型：

次要指标

Outcome：

Pain relief effect and total dosage of opioids: VAS/NRS pain relief scores were conducted at 6 hours, 24 hours, and 48 hours postoperatively, and the total dosage of opioids during the pain relief period was recorded simultaneously.

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：在产后第3天与第30天评估患者对情绪改善、镇痛体验及整体恢复的主观满意度。

指标类型：

次要指标

Outcome：

Patient satisfaction: On the third day and the thirtieth day postpartum, the patients' subjective satisfaction with the improvement of their mood, pain relief experience and overall recovery was evaluated.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

情绪指标：在产后第30天分别使用EPDS和HAMD-17量表评估产妇的抑郁症状程度。

指标类型：

次要指标

Outcome：

Emotional indicators: The degree of depressive symptoms in postpartum women was evaluated using the EPDS and HAMD-17 scales respectively on the 30th day after delivery.

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 40 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

采用计算机生成的随机数字表，将符合条件的产妇按照1:1比例分为干预组与对照组。随机数字表法：参考第 6 版《医学统计学》教材的随机数字表，选取第 6 行第 6 列随机数，沿着向右的方向依次读数，直到取到80个随机数，按顺序依次编号。根据随机数除以 2 的余数，奇数属于艾司氯胺酮组 ，偶数属于对照组，每组 40 例。

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

A computer-generated random number table was used to divide eligible parturients into the intervention group and the control group at a 1:1 ratio. The random number table method: Referring to the random number table in the 6th edition of the "Medical Statistics" textbook, the random number in the 6th row and 6th column was selected, and the numbers were read in sequence from right to left until 80 random numbers were obtained. They were numbered in sequence. According to the remainder of the random number divided by 2, odd numbers belonged to the esketamine group and even numbers belonged to the control group, with 40 cases in each group.

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：

除麻醉医师外，所有参与者均不知情。数据评估和分析由独立的统计人员监督进行。患者、收集数据的临床研究人员以及术后随访的团队对分组分配均不知情。

Blinding：

All participants except the anesthesiologist will be unaware of them. Data assessment and analysis will be supervised by independent statisticians. procedures specified in the trial protocol. Once unblinded, the case with that number will be withdrawn from the trial, and the researcher should record the reason for withdrawal in the case report form.

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）：

平台名称：中国临床试验公共管理平台（ResMan） 访问链接：通过ResMan平台（https://www.medresman.org）开放公众查询。 补充说明：试验完成后6个月内公开全部匿名原始数据，公众可免费直接下载。

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

Platform Name: China Clinical Trial Public Management Platform (ResMan) Access Link: Public inquiries are available through the ResMan platform (https://www.medresman.org). Supplementary Information: All anonymous original data will be made public within six months after the completion of the trial, and the public can download it for free directly.

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：

全程使用ResMan管理数据，采用双人录入与逻辑校验。

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

All data was managed using ResMan, with double-entry and logical verification by two individuals.

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：

  2025-08-11 09:46:54