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Идёт набор NCT06788444

Efficacy of Esketamine for Patients With Irritable Bowel Syndrome

Без фазы С лечением Irritable Bowel Syndrome

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: The colonoscopy, Esketamine.
Кому может быть актуально
Состояния в реестре: Irritable Bowel Syndrome. Базовые параметры: 18 лет — 60 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

Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial

Обзор

To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

Подробное описание

The investigators aim to investigate the efficacy of a single low dose of esketamine in patients with irritable bowel syndrome (IBS), and to explore the etiology of IBS and the effective and rapid treatment for this etiology.

Вмешательства

  • Процедура The colonoscopy
    Both groups continued to receive the usual standard of gastroenterology care throughout the study period. The patients undergo preoperative preparation according to the requirements of colonoscopy. After entering the endoscopy room, the routine monitoring including electrocardiogram, heart rate, noninvasive blood pressure (BP), respiratory rate, and oxygen saturation (SpO2) are applied for patients. All monitoring data including HR, BP and SpO2 will be recorded at intervals of 3min. Safety asses
  • Препарат Esketamine
    The propofol is administered until the patients loss of consciousness (loss of the eyelash refex). The 0.2 mg/kg esketamine is then administered by the anesthesiologist, but should be discontinued if the SBP ≥200 mmHg or the DBP ≥110 mmHg. After the administration of the 0.2 mg/kg esketamine is completed, the endoscopist will begin the colonoscopic procedure.

Первичные конечные точки

  • The IBS Severity Scoring System (IBS-SSS) [Срок оценки: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy]
Вторичные конечные точки (6)
  • The IBS Quality of Life (IBS-QOL) questionnaire [Срок оценки: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy]
  • The Bristol Stool Form (BSF) scale [Срок оценки: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy]
  • The Hospital Anxiety and Depression Scale (HADS) [Срок оценки: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy,]
  • The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score [Срок оценки: At baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy]
  • The respiratory and cardiovascular adverse events [Срок оценки: At baseline and at 24 hours after colonoscopy]
  • The other adverse events [Срок оценки: At baseline and at 24 hours after colonoscopy]

Критерии участия

Критерии включения

  • Age of 18 - 60 years;
  • American Society of Anesthesiologists (ASA) physical status of I - II;
  • Body Mass Index (BMI) of 15 - 30;
  • Scheduled for colonoscopy;
  • Positive screening results according to the Rome IV diagnostic criteria for IBS;
  • Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (MDD) .

Критерии исключения

  • GastrointestinalTract (GI) bleeding;
  • Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；
  • A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;
  • A history of weight loss (at least 10%) within six months;
  • A history of abdominal surgery (other than hernia repair or appendectomy);
  • Participate in other clinical trials within 3 months;
  • Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；
  • Mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;
  • Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;
  • Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;
  • Pregnancy or breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital — Пекин

Публикации

  • Sun Z, Jiang L, Xing Y, Luo F. Efficacy of a single low dose of esketamine for patients with irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2025 Jun 23;15(6):e099793. doi: 10.1136/bmjopen-2025-099793. PMID 40550724

Идентификаторы

NCT: NCT06788444 · KY2024-414-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗