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- Ensaio Clínico NCT07760740
The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery
11 de agosto de 2026 atualizado por: Guolin Wang, Tianjin Medical University General Hospital
The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study
To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
Cholestatic pruritus is a common and refractory symptom in patients undergoing hepatobiliary surgery, often caused by impaired bile excretion due to bile duct stones, biliary tumors, or bile duct strictures.
Patients typically present with moderate to severe pruritus, initially or most severely affecting the palms and soles, which significantly impairs quality of life and is frequently accompanied by sleep disturbances, anxiety, and depression.
Esketamine, as an NMDA receptor antagonist, exhibits anti-hyperalgesic effects and inhibits central sensitization.
Recent studies suggest that it may also alleviate refractory pruritus.
This study aims to investigate the effect of intraoperative continuous infusion of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
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
- Nome: Guolin Wang, Study Director
- Número de telefone: +8615822855556
- E-mail: wangguolinghad@hotmail.com
Locais de estudo
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Tianjin, China
- Tianjin Medical University General Hospital, Tianjin, 300052
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Contato:
- Guolin Wang, Study Director
- Número de telefone: +8615822855556
- E-mail: wangguolinghad@hotmail.com
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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
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
1. Inclusion Criteria:
- Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
- Manifestations of cholestatic pruritus, typically with the palms and soles as the initial or most severely affected sites, which may extend to the limbs and trunk; possibly accompanied by jaundice (yellowing of the skin and sclera), dark urine (e.g., tea-colored), and clay-colored stools; often with a tendency to worsen at night.
- Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
- Scheduled for elective hepatobiliary surgery under general anesthesia, including but not limited to: partial hepatectomy, common bile duct exploration, choledocholithotomy, biliary-enteric anastomosis (e.g., Roux-en-Y anastomosis), pancreaticoduodenectomy (Whipple procedure), and radical resection of hilar cholangiocarcinoma.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
- Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.
Exclusion Criteria:
- Known allergy to any component of the study drug or history of allergic constitution;
- History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
- History of neurological disease; history of chronic pain; substance abuse or alcoholism; long-term use of opioids; administration of opioids within 48 hours prior to surgery;
- ASA physical status classification IV;
- Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
- History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
- Respiratory insufficiency or respiratory failure;
- Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
- Other pruritic disorders: uremic pruritus, polycythemia vera, cutaneous T-cell lymphoma, hypereosinophilia, drug eruption and drug-induced pruritus, as well as other pruritic diseases that may be easily confused, such as atopic dermatitis, pemphigoid, scabies, delusional parasitosis, dermatitis artefacta, etc.;
- Pregnant or breastfeeding women;
- BMI < 18 kg/m² or BMI > 30 kg/m²;
- Poor compliance or inability to complete the study according to the protocol;
- Participation in another drug clinical trial within the past 4 weeks;
- Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Patients receiving esketamine intervention
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.
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Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h
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Comparador de Placebo: Patients receiving an equal volume of saline
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
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Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Prazo: The morning and evening of the first day after the operation
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The patient evaluated the intensity of pruritus with 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: Extremely severe itching.
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The morning and evening of the first day after the operation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
Prazo: On the morning and evening of the second and third days after the operation
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The patient evaluated the intensity of pruritus with 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:Extremely severe itching.
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On the morning and evening of the second and third days after the operation
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The incidence of sleep disorders on postoperative days 1-3
Prazo: The first, second and third days after the surgery
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Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first, second and third day after surgery.
The AIS has a total of 8 items, with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.
The investigators 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 AIS scores as statistical indicators.
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The first, second and third days after the surgery
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Postoperative anxiety
Prazo: 1 day before surgery ,1 -3 days after surgery
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Patients completed the anxiety rating scales (HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery.
HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety.
And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in anxiety.
The investigators recorded HADS-A scores as statistical indicators
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1 day before surgery ,1 -3 days after surgery
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Postoperative depression
Prazo: 1 day before surgery ,1 -3 days after surgery
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Patients completed the depression rating scales (HADS-D, Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery.
HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression.
And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in depression.
The investigators recorded HADS-D scores as statistical indicators.
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1 day before surgery ,1 -3 days after surgery
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Pain Score (NRS)
Prazo: 1-3 days after 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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1-3 days after surgery
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5-D itch scale at 72 hours after surgery
Prazo: 72 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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72 hours after surgery
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Liver function tests (LFTs)
Prazo: Preoperative baseline and postoperative day one
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Preoperative baseline and postoperative day one
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Postoperative Complications
Prazo: Within 72 hours postoperatively
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Within 72 hours postoperatively
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 agosto de 2026
Conclusão Primária (Estimado)
20 de abril de 2027
Conclusão do estudo (Estimado)
20 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
14 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de agosto de 2026
Primeira postagem (Real)
12 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB2025-YX-497-01
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
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