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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07801183
Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy
2 de septiembre de 2026 actualizado por: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
117
Fase
- Fase 4
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
- Nombre: Changzhen Shang
- Número de teléfono: +86-20-3407 0701
- Correo electrónico: shchzh2@mail.sysu.edu.cn
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Contacto:
- Changzhen Shang
- Número de teléfono: +86-20-3407 0701
- Correo electrónico: shchzh2@mail.sysu.edu.cn
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-
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:
- Aged ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
- Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
- Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion Criteria:
- Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
- Patients undergoing emergency surgery or trauma patients;
- Intraoperative conversion to open laparotomy;
- History of abdominal surgery within the past 3 months;
- Patients undergoing liver transplantation or with metastasis to other organs;
- Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
- Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²);
- Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
- Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
- Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
- Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
- Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
- Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Anruikefon 1 μg/kg per dose Group
Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses.
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Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
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|
Experimental: Anruikefon 100 μg per dose Group
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
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Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
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Comparador de placebos: Placebo Group
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
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0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
Periodo de tiempo: 0-48 hours post first study drug dose
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0-48 hours post first study drug dose
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proportion of rescue analgesia
Periodo de tiempo: Within0-24 hours and 0-48 hours after the first study drug administration
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Within0-24 hours and 0-48 hours after the first study drug administration
|
|
Cumulative consumption dose of rescue analgesia
Periodo de tiempo: within 0-24 hours and 0-48 hours after the first study drug administration
|
within 0-24 hours and 0-48 hours after the first study drug administration
|
|
Time from end of surgery to first passage of flatus (hours)
Periodo de tiempo: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
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Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
|
|
Time from end of surgery to first defecation (hours)
Periodo de tiempo: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
|
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
|
|
Time from the end of surgery to first ambulation (hours)
Periodo de tiempo: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
|
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
|
|
Incidence of nausea, vomiting and PONV
Periodo de tiempo: Within 48 hours after the first study drug administration
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Within 48 hours after the first study drug administration
|
|
Patient satisfaction score for analgesia
Periodo de tiempo: Within 48 hours after the first study drug administration
|
Within 48 hours after the first study drug administration
|
|
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3
Periodo de tiempo: Within 0-24 hours and 0-48 hours after the first study drug administration
|
Within 0-24 hours and 0-48 hours after the first study drug administration
|
|
Resting numerical rating scale (NRS) pain score
Periodo de tiempo: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
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At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
|
|
Movement-evoked numerical rating scale (NRS) pain score
Periodo de tiempo: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
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At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
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Incidence of rescue antiemetic treatment
Periodo de tiempo: Within 48 hours after the first study drug administration
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Within 48 hours after the first study drug administration
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Cumulative dose of rescue antiemetic treatment
Periodo de tiempo: Within 48 hours after the first study drug administration
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Within 48 hours after the first study drug administration
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Incidence of serious adverse events and study drug-related adverse events
Periodo de tiempo: Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
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Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
|
|
Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)
Periodo de tiempo: On the single night following the first administration of study drug
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On the single night following the first administration of study drug
|
|
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Periodo de tiempo: Within 24 hours after the first study-drug administration
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Within 24 hours after the first study-drug administration
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|
Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)
Periodo de tiempo: Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
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Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
|
|
Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3
Periodo de tiempo: Within 0-24 hours and 0-48 hours after the first study-drug administration
|
Within 0-24 hours and 0-48 hours after the first study-drug administration
|
|
Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)
Periodo de tiempo: Within 48 hours after the first study-drug administration
|
Within 48 hours after the first study-drug administration
|
|
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)
Periodo de tiempo: Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug
|
Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Changzhen Shang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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)
30 de agosto de 2026
Finalización primaria (Estimado)
1 de julio de 2027
Finalización del estudio (Estimado)
30 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
29 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Técnicas de investigación
- Diseño de investigación epidemiológica
- Métodos epidemiológicos
- Diseño de la investigación
- Métodos
- Características de la población
- Demografía
- Grupos de control
- Grupos de población
Otros números de identificación del estudio
- SYSKY-2026-307-03
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. .