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Идёт набор NCT06777758

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Фаза IV С лечением Postoperative Complications Respiratory Depression Postoperative Nausea Vomiting

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: Postoperative Complications, Respiratory Depression, Postoperative Nausea, Vomiting. Базовые параметры: 20 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
Тайвань
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 Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.

Обзор

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Подробное описание

Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.

Вмешательства

  • Препарат Remimazolam
    Remimazolam
  • Препарат Propofol
    Propofol dose reduction ratio

Первичные конечные точки

  • Dose change [Срок оценки: Perioperatively (during upper gastrointestinal endoscopy)]
Вторичные конечные точки (8)
  • Incidence of postoperative nausea and vomiting. [Срок оценки: After returning to the ward from the recovery room until before breakfast on the first postoperative day.]
  • Time to open eyes after stopping Propofol or Remimazolam. [Срок оценки: The timer starts after the anesthetic is administered.]
  • Use of rescue medications during surgery. [Срок оценки: During surgery]
  • Analgesic dosage in the recovery room. [Срок оценки: Observation period in the postoperative recovery room]
  • Analgesic dosage in the ward. [Срок оценки: The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.]
  • Pain Intensity (Visual Analog Scale, VAS) every 15 minutes in the recovery room for 1 hour after surgery. [Срок оценки: Within 1 hour post-surgery.]
  • Pain from the first injection of medication. [Срок оценки: During the surgery (immediately after the first injection).]
  • Recall of surgery events. [Срок оценки: On postoperative day 1 (within 24 hours after surgery).]

Критерии участия

Критерии включения

  • Subjects are between 20-80 years old.
  • Anesthesiologists rated ASA as between I and III.
  • Patients undergoing upper gastrointestinal endoscopic examination or therapy.

Критерии исключения

  • Allergy to Propofol, Remimazolam, or opioid medications.
  • Emergency surgery.
  • Pregnancy.
  • History of malignant hyperthermia.
  • Impaired liver or kidney function.
  • Airway difficulties due to pharyngeal tumors.
  • Refusal to participate.

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
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Kaohsiung Veterans General Hospital — Kaohsiung City

Публикации

  • Meseeha M, Goosenberg E, Attia M. Endoscopic Retrograde Cholangiopancreatography. 2025 Oct 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493160/ PMID 29630212
  • Garewal D, Waikar P. Propofol sedation for ERCP procedures: a dilemna? Observations from an anesthesia perspective. Diagn Ther Endosc. 2012;2012:639190. doi: 10.1155/2012/639190. Epub 2012 Jan 5. PMID 22272061
  • Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139. PMID 23635608
  • Zhu H, Su Z, Zhou H, Lu J, Wang X, Ji Z, Chen S, Wang X, Yao M, Lu Y, Yu W, Su D. Remimazolam Dosing for Gastroscopy: A Randomized Noninferiority Trial. Anesthesiology. 2024 Mar 1;140(3):409-416. doi: 10.1097/ALN.0000000000004851. PMID 38039392
  • Barbosa EC, Espirito Santo PA, Baraldo S, Meine GC. Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis. Br J Anaesth. 2024 Jun;132(6):1219-1229. doi: 10.1016/j.bja.2024.02.005. Epub 2024 Mar 4. PMID 38443286
  • Dong SA, Guo Y, Liu SS, Wu LL, Wu LN, Song K, Wang JH, Chen HR, Li WZ, Li HX, Zhang L, Yu JB. A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures. J Clin Anesth. 2023 Jun;86:111077. doi: 10.1016/j.jclinane.2023.111077. Epub 2023 Feb 9. PMID 36764022
  • Ahmer W, Imtiaz S, Alam DM, Ahmed K, Sajid B, Yousuf J, Asnani S, Fahim MAA, Ali R, Mansoor M, Safdar MT, Anjum MU, Hasanain M, Larik MO. Remimazolam versus propofol for sedation in gastrointestinal endoscopy and colonoscopy within elderly patients: a meta-analysis of randomized controlled trials. Eur J Clin Pharmacol. 2024 Apr;80(4):493-503. doi: 10.1007/s00228-024-03624-6. Epub 2024 Jan 23. PMID 38261005
  • Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30. PMID 29723512

Идентификаторы

NCT: NCT06777758 · KSVGH24-CT8-16

Первоисточники (государственные реестры)

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