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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Guolin Wang
- 電話番号：15822855556
- メール：wangguolinhad@hotmail.com
研究場所
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Tianjin、中国、300052
- Tianjin Medical University General Hospital
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コンタクト：
- Guolin Wang
- 電話番号：+8618604755166
- メール：wangguolinhad@hotmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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. -
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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5D-IS score at 24 hours after surgery
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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5D-IS score at 48 hours,72 hours and the seventh day after surgery
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intraoperative Anesthesia Information
時間枠：Perioperative period
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Duration of anesthesia (minutes)
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Perioperative period
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Intraoperative Vital Signs
時間枠：Perioperative period
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Intraoperative average heart rate
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Perioperative period
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Adverse Event
時間枠：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
時間枠：Perioperative period
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Duration of surgery (minutes)
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Perioperative period
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Intraoperative Anesthesia Information
時間枠：Perioperative period
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Intraoperative dosage of Sufentanil （μg）
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Perioperative period
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Intraoperative Anesthesia Information
時間枠：Perioperative period
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Intraoperative dosage of Remifentani (mg)
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Perioperative period
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Intraoperative Vital Signs
時間枠：Perioperative period
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intraoperative average blood oxygen saturation
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Perioperative period
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Intraoperative Vital Signs
時間枠：Perioperative period
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Mean Arterial Pressure（MAP）
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Perioperative period
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Guolin Wang、Tianjin Medical University General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月15日
一次修了 (推定)
2027年6月20日
研究の完了 (推定)
2027年9月30日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月18日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB2025-YX-498-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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