Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy

Официальное название

Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial

Обзор

This study aims to evaluate the sedative efficacy and safety of remimazolam combined with oliceridine in elderly patients undergoing painless gastrointestinal endoscopy. Elderly patients often face higher risks of respiratory and hemodynamic depression during clinical sedation. This trial will investigate whether the combination of remimazolam and oliceridine can provide stable sedation, maintain stable vital signs, and reduce the incidence of adverse events such as hypoxemia and postoperative cognitive fluctuation in this vulnerable population.

Подробное описание

This is a clinical study conducted at the Baoshan Branch of Renji Hospital, Shanghai Jiao Tong University School of Medicine. The study will strictly adhere to ethical guidelines, and all research activities will be carried out after receiving full approval from the Ethics Committee.

Elderly participants will be enrolled based on predefined inclusion criteria with comprehensive vulnerability assessments. During the gastrointestinal endoscopy procedure, vital signs, particularly oxygen saturation (SpO2) and its duration of depression, will be monitored closely. To address potential educational bias in cognitive assessments, the study will utilize the Mini-Mental State Examination (MMSE) stratified by years of education alongside the Montreal Cognitive Assessment (MoCA) to comprehensively evaluate postoperative cognitive outcomes. Follow-up assessments will be systematically conducted at designated time points (e.g., 1 week, 1 month, 3 months, and 6 months) post-procedure.

Вмешательства

• Препарат Remimazolam Tosilate for Injection
  Administered intravenously for sedation induction and maintenance during gastrointestinal endoscopy. The dosage will be titrated according to the patient's sedation depth and clinical response.
• Препарат Oliceridine Fumarate
  Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.

Первичные конечные точки

• Incidence of hypoxemia [Срок оценки: From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.]

Вторичные конечные точки (2)

• Incidence of Hypotension [Срок оценки: From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.]
• Sedation success rate [Срок оценки: From the start of sedation induction to the completion of the endoscopic procedure]

Критерии участия

Критерии включения

• Elderly individuals scheduled to undergo painless gastrointestinal endoscopy.
• Age between 65 and 80 years.
• Body mass index (BMI) between 18 and 30 kg/m².
• American Society of Anesthesiologists (ASA) physical status I-III (ASA III patients eligible only with mild-to-moderate dysfunction of a single organ system, without severe organ failure, and considered able to tolerate the procedure).
• Fried frailty phenotype score < 3.
• Mini-Mental State Examination (MMSE) score ≥ 27.
• Provision of written informed consent by the patient or legal representative.

Критерии исключения

• Allergy or contraindication to remimazolam, oliceridine, or sufentanil.
• Liver or renal failure (Child-Pugh class C or eGFR < 30 mL/min).
• Systemic infection, immunosuppression, coagulation disorder, upper gastrointestinal bleeding, or intestinal obstruction.
• History of opioid dependence or long-term use of psychotropic drugs.
• Difficult airway or severe respiratory dysfunction.
• Cognitive impairment, psychiatric disease, or inability to cooperate with assessment.
• New York Heart Association (NYHA) functional class III or higher\[cite: 3\].
• Fried frailty phenotype score ≥ 3.
• Use of sedative or analgesic drugs within 24 hours before enrollment.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch) — Шанхай

Идентификаторы

NCT: NCT07707258 · 2025-E-58 · 2025-E-58

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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