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

18 de maio de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

200

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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. -

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de 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.
Medicamento: Normal Saline
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
Comparador Ativo: 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.
Medicamento: Esketamine
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
5D-IS score at 24 hours after surgery
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
5D-IS score at 48 hours,72 hours and the seventh day after surgery
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Intraoperative Anesthesia Information
Prazo: Perioperative period
Duration of anesthesia (minutes)
Perioperative period
Intraoperative Vital Signs
Prazo: Perioperative period
Intraoperative average heart rate
Perioperative period
Adverse Event
Prazo: 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
Prazo: Perioperative period
Duration of surgery (minutes)
Perioperative period
Intraoperative Anesthesia Information
Prazo: Perioperative period
Intraoperative dosage of Sufentanil （μg）
Perioperative period
Intraoperative Anesthesia Information
Prazo: Perioperative period
Intraoperative dosage of Remifentani (mg)
Perioperative period
Intraoperative Vital Signs
Prazo: Perioperative period
intraoperative average blood oxygen saturation
Perioperative period
Intraoperative Vital Signs
Prazo: Perioperative period
Mean Arterial Pressure（MAP）
Perioperative period

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tianjin Medical University General Hospital

Investigadores

  • Diretor de estudo: Guolin Wang, Tianjin Medical University General Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de maio de 2026

Conclusão Primária (Estimado)

20 de junho de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB2025-YX-498-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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