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Идёт набор NCT06187896

The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients

Без фазы С лечением Hypoxia Hysteroscopy Overweight or Obesity

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: remimazolam, Propofol.
Кому может быть актуально
Состояния в реестре: Hypoxia, Hysteroscopy, Overweight or Obesity. Базовые параметры: 20 лет — 50 лет · Женщины.
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 Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial

Обзор

Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and it is more likely to occur in overweight or obese patients. In sedated gastroscopy, the incidence of hypoxia with remimazolam is lower than that with propofol. The present study is a single-center, randomized, single-blind, controlled clinical trial. Overweight or obese patients undergoing sedated hysteroscopy for diagnosis and treatment, with ASA grade I or II, were selected as subjects and randomly divided into an experimental group and a control group, with 300 subjects in each group. Sedation induction and maintenance are performed using remimazolam or propofol combined with remifentanil, respectively, to compare the incidence of severe hypoxia during surgery between the two groups of patients.

Вмешательства

  • Препарат remimazolam
    in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
  • Препарат Propofol
    in this group,patients are treated with propofol and remifentanil for reduced sedation.

Первичные конечные точки

  • The incidence of severe hypoxia [Срок оценки: people will be followed for the duration of hospital stay,an expected average about 2 hours]
Вторичные конечные точки (3)
  • The incidence of hypoxia [Срок оценки: people will be followed for the duration of hospital stay,an expected average about 2 hours]
  • The incidence of sub-clinical respiratory depression [Срок оценки: people will be followed for the duration of hospital stay,an expected average about 2 hours]
  • The incidence of other adverse events [Срок оценки: people will be followed for the duration of hospital stay,an expected average about 2 hours]

Критерии участия

Критерии включения

  • Age between 20 and 50 years.
  • Patients undergoing sedated hysteroscopy for assisted reproduction.
  • ASA classification I-II.
  • BMI ≥ 23 kg/㎡.
  • Patients who have signed an informed consent form.

Критерии исключения

  • SpO2 < 95% in patients inhaling air upon entering the room.
  • Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy.
  • Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.
  • Patients with severe liver dysfunction.
  • Patients with severe renal insufficiency (requiring dialysis before surgery).
  • Severe heart failure (METS < 4).
  • History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).
  • Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
  • Breastfeeding women.
  • Patients whom investigator believe are unsuitable for participating in this trial.

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
Профилактика

Центры проведения

Китай · 1 центр
  • Diansan Su — Шанхай

Публикации

  • He Y, Zhou J, Ding X, Huai X, Lin S, Yu W, Su D. The effects of remimazolam on the incidence of severe hypoxemia during sedated hysteroscopy for assisted reproduction in overweight or obese patients: a randomized controlled clinical trial. Trials. 2025 Aug 26;26(1):309. doi: 10.1186/s13063-025-09054-8. PMID 40859372

Идентификаторы

NCT: NCT06187896 · remi-zhoujie

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗