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The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients

18. Mai 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Meet the diagnostic criteria for senile pruritus:

    1. Aged ≥ 65 years old;
    2. Presenting with only skin pruritus without obvious primary skin lesions, with or without scratch-induced skin lesions;
    3. Daily or nearly daily pruritus lasting for more than 6 weeks.
  2. Patients undergoing elective general anesthesia for orthopedic knee arthroplasty.
  3. 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.
  4. 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:

  1. Those who are allergic to the pharmaceutical ingredients of this study or have an allergic constitution;
  2. Those with a history of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
  3. 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;
  4. Patients with ASA physical status classification Grade IV-V;
  5. 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;
  6. Those with a history of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
  7. Those with respiratory insufficiency or respiratory failure;
  8. Those with BMI < 18 kg/m² or BMI > 30 kg/m²;
  9. Those with poor compliance who cannot complete the trial in accordance with the research protocol;
  10. Those who have participated in other clinical drug trials within the past 4 weeks;
  11. Those deemed unsuitable for enrollment by the researchers for any reason. -

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: 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.
Arzneimittel: Normal Saline
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
Aktiver Komparator: 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.
Arzneimittel: Esketamine
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
5D-IS score at 24 hours after surgery
Zeitfenster: 24 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.
24 hours after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
5D-IS score at 48 hours,72 hours and the seventh day after surgery
Zeitfenster: 48 hours,72 hours and the seventh day 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.
48 hours,72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
Zeitfenster: 24 hours after surgery
The 5D-IS score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator.
24 hours after surgery
NRS pruritus score at 24 hours,48 hours and 72 hours after surgery
Zeitfenster: 24 hours,48 hours and 72 hours after surgery
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.
24 hours,48 hours and 72 hours after surgery
Pain Score (NRS)
Zeitfenster: 1 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.
1 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first. second and third postoperative nights
Zeitfenster: the first,second and third nights after surgery
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.
the first,second and third nights after surgery
Montreal Cognitive Assessment (MoCA)
Zeitfenster: 24 hours, 48 hours, 72 hours after the surgery
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.
24 hours, 48 hours, 72 hours after the surgery
Confusion Assessment Method (CAM)
Zeitfenster: 24 hours, 48 hours, 72 hours after the surgery
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.
24 hours, 48 hours, 72 hours after the surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intraoperative Anesthesia Information
Zeitfenster: Perioperative period
Duration of anesthesia (minutes)
Perioperative period
Intraoperative Vital Signs
Zeitfenster: Perioperative period
Intraoperative average heart rate
Perioperative period
Adverse Event
Zeitfenster: 1 hour, 24 hours, 48 hours and 72 hours after surgery
All kinds of adverse events(nausea, vomiting, respiratory depression, headache, dizziness, chills, delayed recovery from anesthesia) occurred in patients were recorded.
1 hour, 24 hours, 48 hours and 72 hours after surgery
Intraoperative Anesthesia Information
Zeitfenster: Perioperative period
Duration of surgery (minutes)
Perioperative period
Intraoperative Anesthesia Information
Zeitfenster: Perioperative period
Intraoperative dosage of Sufentanil （μg）
Perioperative period
Intraoperative Anesthesia Information
Zeitfenster: Perioperative period
Intraoperative dosage of Remifentani (mg)
Perioperative period
Intraoperative Vital Signs
Zeitfenster: Perioperative period
intraoperative average blood oxygen saturation
Perioperative period
Intraoperative Vital Signs
Zeitfenster: Perioperative period
Mean Arterial Pressure（MAP）
Perioperative period

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tianjin Medical University General Hospital

Ermittler

  • Studienleiter: Guolin Wang, Tianjin Medical University General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2026

Primärer Abschluss (Geschätzt)

20. Juni 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB2025-YX-498-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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