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The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy

2026年4月23日 更新者：Guolin Wang、Tianjin Medical University General Hospital

The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial

To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels.

Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients.

Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.

研究类型

介入性

注册 (估计的)

160

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Tianjin、中国、300052
        • Tianjin Medical University General Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
  2. Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
  3. Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L.
  4. Reporting pruritus NRS ≥ 4 points twice within one week.
  5. Planned to undergo cesarean section under intraspinal anesthesia.
  6. ASA classification: I - III grade.

Exclusion Criteria:

  1. Those who are known to be allergic to the drug components or have an allergic constitution.
  2. Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.
  3. Those with severe organic diseases and liver diseases.
  4. Those with malignant tumors.
  5. Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.
  6. Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
  7. ASA classification as grade IV.
  8. Those with poor compliance and unable to complete the trial according to the research protocol.
  9. Those who have participated in other drug clinical trials within the past 4 weeks.

  10. Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.

    -

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo group of parturients with ICP and pruritus received normal saline
The equal volume of normal saline was injected intravenously after fetal delivery during the operation
药品：Normal Saline (0.9% NaCl)
The same volume of normal saline was injected after fetal delivery during the operation
有源比较器：Group of parturients with ICP and pruritus received esketamine 0.3mg/kg
Esketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation
药品：Esketamine 0.3mg/kg
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
NRS pruritus score at 24 hours after surgery
大体时间：24 hours after the surgery
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
24 hours after the surgery

次要结果测量

结果测量
措施说明
大体时间
5-D itch scale at 72 hours after surgery
大体时间：72 hours after surgery
The duration, severity, outcome trend, life impairment, and pruritus site (5-D) were used to evaluate the patient's pruritus. Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25. The higher the score, the more severe the itching.
72 hours after surgery
NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery
大体时间：6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
大体时间：24 hours after surgery
The NRS pruritus score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator.
24 hours after surgery
Total bile acid at 24 hours after surgery
大体时间：24 hours after surgery
The patient's fasting total bile acid level was checked the day before the operation. The investigators rechecked the fasting total bile acid levels 24 hours after the patient's surgery to assess the changes in total bile acid.
24 hours after surgery
Pain Score (NRS)
大体时间：6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first、second and third postoperative nights
大体时间：the first、second and third nights after surgery
The patient completed the Sleep Quality Scale (AIS，Athens Insomnia Scale) one day before the surgery. There are a total of 8 items in the AIS, with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire after the first, second and third postoperative nights to evaluate the changes in sleep quality. The investigators recorded AIS scores as statistical indicators.
the first、second and third nights after surgery
Postoperative anxiety
大体时间：72 hours after the surgery
The patient completed the Self-Rating Anxiety Scale (SAS, Self-Rating Anxiety Scale) one day before the surgery. The SAS consists of 20 items. Among them, 15 items are positive ratings (such as "I feel more nervous and anxious than usual"), and 5 items are negative ratings (such as "I feel everything is fine", which are the reverse items numbered 5, 9, 13, 17, and 19). The content covers subjective feelings of anxiety and various physical symptoms. The investigators asked the patient to fill out this questionnaire again 72 hours after the surgery to assess the changes in anxiety.
72 hours after the surgery
Postoperative depression
大体时间：72 hours after the surgery
The patient completed the Edinburgh Depression Scale (EPDS) one day before the surgery. The EPDS consists of 10 items, covering aspects such as mood, anxiety, and self-blame. Scores range from 0 to 9: within the normal range, no special intervention is required; 10-12: borderline range, suggesting a need for follow-up observation; 13-30: screening positive, indicating possible postpartum depression, and further assessment is necessary. The investigators asked the patient to fill out this questionnaire again at the seventy-second hour after the surgery to assess the changes in depression.
72 hours after the surgery
Key time points of the surgery
大体时间：Perioperative period
  1. Duration of anesthesia （minutes）
  2. Duration of surgery （minutes）
  3. The time of fetal delivery（minutes）
Perioperative period
Intraoperative average blood pressure（mmHg）
大体时间：Perioperative period
Perioperative period
Intraoperative average heart rate（times per minute）
大体时间：Perioperative period
Perioperative period
Intraoperative average blood oxygen saturation（%）
大体时间：Perioperative period
Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
大体时间：Perioperative period
Perioperative period
Adverse event
大体时间：Within 72 hours after the surgery
All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded.
Within 72 hours after the surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tianjin Medical University General Hospital

调查人员

  • 研究主任：Guolin Wang、Tianjin Medical University General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月5日

初级完成 (估计的)

2027年5月5日

研究完成 (估计的)

2027年8月11日

研究注册日期

首次提交

2026年4月10日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月23日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB2026-YX-129-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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