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The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery

11 de agosto de 2026 actualizado 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Tianjin, Porcelana
        • Tianjin Medical University General Hospital, Tianjin, 300052
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 1. Inclusion Criteria:

    1. Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
    2. 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.
    3. Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
    4. 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.
    5. American Society of Anesthesiologists (ASA) physical status classification I-III.
    6. Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
    7. Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.

Exclusion Criteria:

  1. Known allergy to any component of the study drug or history of allergic constitution;
  2. History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
  3. 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;
  4. ASA physical status classification IV;
  5. Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
  6. History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
  7. Respiratory insufficiency or respiratory failure;
  8. Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
  9. 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.;
  10. Pregnant or breastfeeding women;
  11. BMI < 18 kg/m² or BMI > 30 kg/m²;
  12. Poor compliance or inability to complete the study according to the protocol;
  13. Participation in another drug clinical trial within the past 4 weeks;
  14. Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Patients receiving esketamine intervention
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.
Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h
Comparador de placebos: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Periodo de tiempo: The morning and evening of the first day after the operation
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.
The morning and evening of the first day after the operation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
Periodo de tiempo: On the morning and evening of the second and third days after the operation
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.
On the morning and evening of the second and third days after the operation
The incidence of sleep disorders on postoperative days 1-3
Periodo de tiempo: The first, second and third days after the surgery
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.
The first, second and third days after the surgery
Postoperative anxiety
Periodo de tiempo: 1 day before surgery ,1 -3 days after surgery
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
1 day before surgery ,1 -3 days after surgery
Postoperative depression
Periodo de tiempo: 1 day before surgery ,1 -3 days after surgery
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.
1 day before surgery ,1 -3 days after surgery
Pain Score (NRS)
Periodo de tiempo: 1-3 days after 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.
1-3 days after surgery
5-D itch scale at 72 hours after surgery
Periodo de tiempo: 72 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
72 hours after surgery
Liver function tests (LFTs)
Periodo de tiempo: Preoperative baseline and postoperative day one
  1. Alanine Transaminase, ALT
  2. Aspartate Aminotransferase, AST
  3. Total Bilirubin, TBil
  4. Direct Bilirubin, DBIL
  5. Alkaline phosphatase, ALP
  6. Gamma-glutamyltransferase, GGT
Preoperative baseline and postoperative day one
Postoperative Complications
Periodo de tiempo: Within 72 hours postoperatively
  1. Nausea and vomiting
  2. Dizziness
  3. Nightmare
  4. Respiratory depression
  5. hallucinations
Within 72 hours postoperatively

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de agosto de 2026

Finalización primaria (Estimado)

20 de abril de 2027

Finalización del estudio (Estimado)

20 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de agosto de 2026

Publicado por primera vez (Actual)

12 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB2025-YX-497-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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