The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients
2026년 5월 18일 업데이트: 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
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Guolin Wang
- 전화번호: 15822855556
- 이메일: wangguolinhad@hotmail.com
연구 장소
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Tianjin, 중국, 300052
- Tianjin Medical University General Hospital
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연락하다:
- Guolin Wang
- 전화번호: +8618604755166
- 이메일: wangguolinhad@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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. -
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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5D-IS score at 24 hours after surgery
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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5D-IS score at 48 hours,72 hours and the seventh day after surgery
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intraoperative Anesthesia Information
기간: Perioperative period
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Duration of anesthesia (minutes)
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Perioperative period
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Intraoperative Vital Signs
기간: Perioperative period
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Intraoperative average heart rate
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Perioperative period
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Adverse Event
기간: 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
기간: Perioperative period
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Duration of surgery (minutes)
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Perioperative period
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Intraoperative Anesthesia Information
기간: Perioperative period
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Intraoperative dosage of Sufentanil （μg）
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Perioperative period
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Intraoperative Anesthesia Information
기간: Perioperative period
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Intraoperative dosage of Remifentani (mg)
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Perioperative period
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Intraoperative Vital Signs
기간: Perioperative period
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intraoperative average blood oxygen saturation
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Perioperative period
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Intraoperative Vital Signs
기간: Perioperative period
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Mean Arterial Pressure（MAP）
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Perioperative period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Guolin Wang, Tianjin Medical University General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 15일
기본 완료 (추정된)
2027년 6월 20일
연구 완료 (추정된)
2027년 9월 30일
연구 등록 날짜
최초 제출
2026년 5월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 18일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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