The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients
2026年5月18日 更新者：Guolin Wang、Tianjin Medical University General Hospital
The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients: A Single-Center Randomized Controlled Trial
To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery
研究概览
详细说明
Pruritus (itching) is one of the most common clinical conditions in the elderly population.
Its etiology is complex, and the prevalence gradually increases with age.
Pruritus in the elderly not only imposes a significant disease burden but also severely affects their sleep quality and daily life.
This chronic, persistent itching often disrupts the skin barrier function, easily creating a vicious itch-scratch cycle, which leads to multiple damages to the patient's quality of life.Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyHD-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 importantrole in the transmission of non-histaminergic itching.
However, there is still a lack of reports on whether it can relieve pruritus symptoms in elderly patients.
This experiment intends to investigate the effect of intraoperative esketamine infusion on skin pruritus in elderly surgical patients.
研究类型
介入性
注册 (估计的)
200
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
- 姓名：Guolin Wang
- 电话号码：15822855556
- 邮箱：wangguolinhad@hotmail.com
学习地点
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Tianjin、中国、300052
- Tianjin Medical University General Hospital
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接触：
- Guolin Wang
- 电话号码：+8618604755166
- 邮箱：wangguolinhad@hotmail.com
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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
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Meet the diagnostic criteria for senile pruritus:
- Aged ≥ 65 years old;
- Presenting with only skin pruritus without obvious primary skin lesions, with or without scratch-induced skin lesions;
- Daily or nearly daily pruritus lasting for more than 6 weeks.
- Patients undergoing elective general anesthesia for orthopedic knee arthroplasty.
- Patients aged ≥ 65 years old, with ASA physical status classification Ⅰ-Ⅲ; BMI ranging from 18 to 30 kg/m², with no restriction on gender.
- Patients have fully understood the nature of this study, are capable of understanding and completing evaluation scales preoperatively, voluntarily participate in this trial, and sign the informed consent form.
Exclusion Criteria:
- Those who are allergic to the pharmaceutical ingredients of this study or have an allergic constitution;
- Those with a history of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
- Those with severe cognitive impairment, a history of neurological diseases, chronic pain, drug addiction, alcoholism, long-term opioid use, or administration of opioids within 48 hours before surgery;
- Patients with ASA physical status classification Grade IV-V;
- Those with severe coronary heart disease/arrhythmia/cardiac insufficiency, bronchial asthma, severe hypertension, severe hematopoietic system dysfunction, severe abnormal liver and kidney function, or significant electrolyte disorders;
- Those with a history of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
- Those with respiratory insufficiency or respiratory failure;
- Those with BMI < 18 kg/m² or BMI > 30 kg/m²;
- Those with poor compliance who cannot complete the trial in accordance with the research protocol;
- Those who have participated in other clinical drug trials within the past 4 weeks;
- Those deemed unsuitable for enrollment by the researchers for any reason. -
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 |
|---|---|
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安慰剂比较：Elderly patients with senile pruritus receive normal saline.
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
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An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
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有源比较器：Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg.
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
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Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
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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 |
|---|---|---|
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5D-IS score at 24 hours after surgery
大体时间：24 hours after surgery
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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.
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24 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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5D-IS score at 48 hours,72 hours and the seventh day after surgery
大体时间：48 hours,72 hours and the seventh day after surgery
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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.
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48 hours,72 hours and the seventh day after surgery
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The incidence of pruritus on the 24 hours after surgery
大体时间：24 hours after surgery
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The 5D-IS score was completed by the patient 24 hours after the operation.
The investigators recorded this score as a statistical indicator.
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24 hours after surgery
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NRS pruritus score at 24 hours,48 hours and 72 hours after surgery
大体时间：24 hours,48 hours and 72 hours after surgery
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The patient evaluated the intensiy of prurtus wth 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; Extrermely severe itching.
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24 hours,48 hours and 72 hours after surgery
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Pain Score (NRS)
大体时间：1 hours, 24 hours, 48 hours, 72 hours after the surgery
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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.
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1 hours, 24 hours, 48 hours, 72 hours after the surgery
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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
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The patient completed the Sleep Quality Scale (AlS, Athens Insomnia Scale) one day before the surgery, There are a totat of 8 items in the AlS,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 AlS scores as statistical indicators.
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the first,second and third nights after surgery
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Montreal Cognitive Assessment (MoCA)
大体时间：24 hours, 48 hours, 72 hours after the surgery
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The Montreal Cognitive Assessment consists of 7 items, which evaluate visuospatial and executive function (5 points), naming (3 points), attention (6 points), language (3 points), abstract thinking (2 points), delayed recall (5 points), and orientation (6 points) respectively.
A total score of ≥26 points indicates basically normal cognitive function; a total score of <25 points suggests cognitive decline.
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24 hours, 48 hours, 72 hours after the surgery
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Confusion Assessment Method (CAM)
大体时间：24 hours, 48 hours, 72 hours after the surgery
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Confusion Assessment Method CAM is assessed based on four core features.
Feature 1: Acute onset or fluctuating course; Feature 2: Inattention; Feature 3: Disorganized thinking; Feature 4: Altered level of consciousness.
The diagnosis of delirium requires a positive result for Feature 1 + a positive result for Feature 2 + a positive result for either Feature 3 or Feature 4.
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24 hours, 48 hours, 72 hours after the surgery
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative Anesthesia Information
大体时间：Perioperative period
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Duration of anesthesia (minutes)
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Perioperative period
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Intraoperative Vital Signs
大体时间：Perioperative period
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Intraoperative average heart rate
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Perioperative period
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Adverse Event
大体时间：1 hour, 24 hours, 48 hours and 72 hours after surgery
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All kinds of adverse events(nausea, vomiting, respiratory depression, headache, dizziness, chills, delayed recovery from anesthesia) occurred in patients were recorded.
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1 hour, 24 hours, 48 hours and 72 hours after surgery
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Intraoperative Anesthesia Information
大体时间：Perioperative period
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Duration of surgery (minutes)
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Perioperative period
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Intraoperative Anesthesia Information
大体时间：Perioperative period
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Intraoperative dosage of Sufentanil （μg）
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Perioperative period
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Intraoperative Anesthesia Information
大体时间：Perioperative period
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Intraoperative dosage of Remifentani (mg)
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Perioperative period
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Intraoperative Vital Signs
大体时间：Perioperative period
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intraoperative average blood oxygen saturation
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Perioperative period
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Intraoperative Vital Signs
大体时间：Perioperative period
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Mean Arterial Pressure（MAP）
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Perioperative period
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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。
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15日
初级完成 (估计的)
2027年6月20日
研究完成 (估计的)
2027年9月30日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年5月19日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.