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

18 mai 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Tianjin, Chine, 300052
        • Tianjin Medical University General Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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. -

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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.
Médicament: Normal Saline
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
Comparateur actif: 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.
Médicament: Esketamine
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
5D-IS score at 24 hours after surgery
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
5D-IS score at 48 hours,72 hours and the seventh day after surgery
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Intraoperative Anesthesia Information
Délai: Perioperative period
Duration of anesthesia (minutes)
Perioperative period
Intraoperative Vital Signs
Délai: Perioperative period
Intraoperative average heart rate
Perioperative period
Adverse Event
Délai: 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
Délai: Perioperative period
Duration of surgery (minutes)
Perioperative period
Intraoperative Anesthesia Information
Délai: Perioperative period
Intraoperative dosage of Sufentanil （μg）
Perioperative period
Intraoperative Anesthesia Information
Délai: Perioperative period
Intraoperative dosage of Remifentani (mg)
Perioperative period
Intraoperative Vital Signs
Délai: Perioperative period
intraoperative average blood oxygen saturation
Perioperative period
Intraoperative Vital Signs
Délai: Perioperative period
Mean Arterial Pressure（MAP）
Perioperative period

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tianjin Medical University General Hospital

Les enquêteurs

  • Directeur d'études: Guolin Wang, Tianjin Medical University General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 mai 2026

Achèvement primaire (Estimé)

20 juin 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

19 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB2025-YX-498-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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