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Идёт набор NCT07514637

Safety and Efficacy of Anricfen for Postoperative Analgesia and Rehabilitation Promotion After Pancreaticoduodenectomy.Intervention Measures: For Normal Adults, Administer Ariceptin Injection Intravenously Post-operation at a Dose of 1 μg/Kgevery 8 Hours for Three Consecutive Days After Surgery.

Фаза II С лечением Patients Who Undergo Pancreaticoduodenectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Experimental Group, Anrikefon.
Кому может быть актуально
Состояния в реестре: Patients Who Undergo Pancreaticoduodenectomy. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study

Обзор

Exploring the effectiveness and safety of early use of Ariceptinfen after pancreaticoduodenectomy in alleviating postoperative pain and promoting recovery of patients. Main objective: To explore the analgesic effect of Anricfen after pancreaticoduodenectomy. Secondary objective: To explore the impact of Anricfen on the accelerated recovery after pancreaticoduodenectomy. Exploratory objective: To investigate the biomarkers of Anricfen's analgesic effect after pancreaticoduodenectomy, as well as its correlation factors with tumor pathology.

Вмешательства

  • Препарат Experimental Group
    Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.
  • Препарат Anrikefon
    Postoperatively, intravenous injection of Anrikefon injection was administered at a dose of 1 μg/kg, every 8 hours, for three consecutive days as an intervention

Первичные конечные точки

  • The incidence of postoperative complications [Срок оценки: After undergoing treatment for 2 months]
  • Incidence rate of adverse events [Срок оценки: Two month after the treatment]
  • The VAS score within 0-72 hours after the operation [Срок оценки: Within 3 days after receiving treatment]
Вторичные конечные точки (8)
  • Changes in biochemical indicators and inflammatory indicators [Срок оценки: One week after the treatment]
  • The time of first flatus and defecation after surgery, and the time to get out of bed for activities [Срок оценки: One week after the treatment]
  • Postoperative hospital stay and hospitalization costs [Срок оценки: After undergoing treatment for 2 months]
  • Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained. [Срок оценки: Within 3 days after receiving treatment]
  • The initial pressing time of the postoperative analgesic pump, the total number of presses, and the number of effective presses [Срок оценки: One day after the treatment]
  • The time for discontinuing postoperative analgesics [Срок оценки: After undergoing treatment for 2 months]
  • The proportion and duration of VAS scores ≤ 3 points within 0-12 hours and 0-24 hours after the first postoperative administration [Срок оценки: Within one day after receiving treatment]
  • The timing and dosage of remedial analgesia [Срок оценки: After undergoing treatment for 2 months]

Критерии участия

Критерии включения

  • Patients who underwent pancreatic surgery, including pancreaticoduodenectomy (PD), pancreatic-preserving pancreaticoduodenectomy (PPPD), and laparoscopic pancreaticoduodenectomy (LPD)
  • Age ≥ 18 years old and < 80 years old
  • ASA Ⅰ-Ⅲ
  • Be able to clearly understand and voluntarily participate in the research

Критерии исключения

  • Merging severe primary diseases involving the heart, brain, liver, kidneys and hematopoietic system
  • History of long-term use of psychotropic drugs and cognitive dysfunction
  • Having a history of acute poisoning from alcohol, sleeping pills, painkillers or other drugs that affect the central nervous system
  • Pregnancy or lactation period
  • History of allergy to NSAIDs, opioids, or to the test medication
  • Drug users, alcoholics, and opiate abusers
  • Those who had a history of chronic pain before the operation and a history of long-term use of analgesics and/or sedatives
  • Those who had thyroid dysfunction before the operation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • NanJing drum tower hospital — Нанкин

Идентификаторы

NCT: NCT07514637 · 2025-0770-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗