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The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery

2026年8月11日 更新者:Guolin Wang、Tianjin Medical University General Hospital

The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study

To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery

研究概览

详细说明

Cholestatic pruritus is a common and refractory symptom in patients undergoing hepatobiliary surgery, often caused by impaired bile excretion due to bile duct stones, biliary tumors, or bile duct strictures. Patients typically present with moderate to severe pruritus, initially or most severely affecting the palms and soles, which significantly impairs quality of life and is frequently accompanied by sleep disturbances, anxiety, and depression. Esketamine, as an NMDA receptor antagonist, exhibits anti-hyperalgesic effects and inhibits central sensitization. Recent studies suggest that it may also alleviate refractory pruritus. This study aims to investigate the effect of intraoperative continuous infusion of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery

研究类型

介入性

注册 (估计的)

100

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

      • Tianjin、中国
        • Tianjin Medical University General Hospital, Tianjin, 300052
        • 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
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 1. Inclusion Criteria:

    1. Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
    2. Manifestations of cholestatic pruritus, typically with the palms and soles as the initial or most severely affected sites, which may extend to the limbs and trunk; possibly accompanied by jaundice (yellowing of the skin and sclera), dark urine (e.g., tea-colored), and clay-colored stools; often with a tendency to worsen at night.
    3. Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
    4. Scheduled for elective hepatobiliary surgery under general anesthesia, including but not limited to: partial hepatectomy, common bile duct exploration, choledocholithotomy, biliary-enteric anastomosis (e.g., Roux-en-Y anastomosis), pancreaticoduodenectomy (Whipple procedure), and radical resection of hilar cholangiocarcinoma.
    5. American Society of Anesthesiologists (ASA) physical status classification I-III.
    6. Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
    7. Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.

Exclusion Criteria:

  1. Known allergy to any component of the study drug or history of allergic constitution;
  2. History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
  3. History of neurological disease; history of chronic pain; substance abuse or alcoholism; long-term use of opioids; administration of opioids within 48 hours prior to surgery;
  4. ASA physical status classification IV;
  5. Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
  6. History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
  7. Respiratory insufficiency or respiratory failure;
  8. Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
  9. Other pruritic disorders: uremic pruritus, polycythemia vera, cutaneous T-cell lymphoma, hypereosinophilia, drug eruption and drug-induced pruritus, as well as other pruritic diseases that may be easily confused, such as atopic dermatitis, pemphigoid, scabies, delusional parasitosis, dermatitis artefacta, etc.;
  10. Pregnant or breastfeeding women;
  11. BMI < 18 kg/m² or BMI > 30 kg/m²;
  12. Poor compliance or inability to complete the study according to the protocol;
  13. Participation in another drug clinical trial within the past 4 weeks;
  14. Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.

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:预防
  • 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
有源比较器:Patients receiving esketamine intervention
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.
Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h
安慰剂比较:Patients receiving an equal volume of saline
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.

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 scores for pruritus assessed in the morning and evening on postoperative day 1
大体时间:The morning and evening of the first day after the operation
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.
The morning and evening of the first day after the operation

次要结果测量

结果测量
措施说明
大体时间
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
大体时间:On the morning and evening of the second and third days after the operation
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.
On the morning and evening of the second and third days after the operation
The incidence of sleep disorders on postoperative days 1-3
大体时间:The first, second and third days after the surgery
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first, second and third day after surgery. The AIS has a total of 8 items, with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia. The investigators 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 days after the surgery
Postoperative anxiety
大体时间:1 day before surgery ,1 -3 days after surgery
Patients completed the anxiety rating scales (HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery. HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety. And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in anxiety. The investigators recorded HADS-A scores as statistical indicators
1 day before surgery ,1 -3 days after surgery
Postoperative depression
大体时间:1 day before surgery ,1 -3 days after surgery
Patients completed the depression rating scales (HADS-D, Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery. HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression. And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in depression. The investigators recorded HADS-D scores as statistical indicators.
1 day before surgery ,1 -3 days after surgery
Pain Score (NRS)
大体时间:1-3 days after 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.
1-3 days after surgery
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
Liver function tests (LFTs)
大体时间:Preoperative baseline and postoperative day one
  1. Alanine Transaminase, ALT
  2. Aspartate Aminotransferase, AST
  3. Total Bilirubin, TBil
  4. Direct Bilirubin, DBIL
  5. Alkaline phosphatase, ALP
  6. Gamma-glutamyltransferase, GGT
Preoperative baseline and postoperative day one
Postoperative Complications
大体时间:Within 72 hours postoperatively
  1. Nausea and vomiting
  2. Dizziness
  3. Nightmare
  4. Respiratory depression
  5. hallucinations
Within 72 hours postoperatively

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。

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8月15日

初级完成 (估计的)

2027年4月20日

研究完成 (估计的)

2027年4月20日

研究注册日期

首次提交

2026年4月14日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB2025-YX-497-01

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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