Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy (RMZ-OLI-ENDO)
17 de julio de 2026 actualizado por: Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
240
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ling long Gong, PhD
- Número de teléfono: +86-17317107780
- Correo electrónico: 350552970@qq.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200444
- Reclutamiento
- Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)
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Contacto:
- Linglong Gong, MD
- Número de teléfono: +86-17317107780
- Correo electrónico: 17317107780@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Remimazolam + Oliceridine Group
Patients in this group will receive a combination of remimazolam and oliceridine for sedation during painless gastrointestinal endoscopy.
Remimazolam will be administered intravenously for induction and maintenance of sedation, titrated to achieve an appropriate depth of anesthesia.
Oliceridine will be administered intravenously to provide stable analgesic cooperation and reduce sedation-related adverse events.
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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.
Otros nombres:
Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.
Otros nombres:
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Comparador activo: Active Control Group
Patients in this group will receive standard remimazolam monotherapy (or remimazolam combined with traditional opioids) for sedation during painless gastrointestinal endoscopy.
remimazolam will be administered intravenously to induce and maintain the sedation required for the endoscopic procedure, adhering to standard clinical anesthesia management protocols.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of hypoxemia
Periodo de tiempo: From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.
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The proportion of participants who experience at least one episode of hypoxemia during procedural sedation for gastrointestinal endoscopy.
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) < 90%.
SpO₂ will be continuously monitored throughout the observation period.
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From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Hypotension
Periodo de tiempo: From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.
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The proportion of participants who experience at least one episode of hypotension during procedural sedation.
Hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from the pre-induction baseline.
MAP will be recorded at baseline and monitored throughout the observation period.
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From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.
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Sedation success rate
Periodo de tiempo: From the start of sedation induction to the completion of the endoscopic procedure
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The proportion of patients who achieve a satisfactory sedation depth (MOAA/S score ≤ 1) without the need for rescue sedative medications.
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From the start of sedation induction to the completion of the endoscopic procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de julio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-E-58 (Otro número de subvención/financiamiento: Shanghai Baoshan District Science and Technology Commission)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Due to the inclusion of sensitive clinical and private information of elderly patients, full individual participant data (IPD) cannot be made publicly available as it was not explicitly authorized in the patient informed consent.
To protect patient privacy and ensuring data security, the raw IPD will not be shared on public platforms.
De-identified data may be available from the corresponding author upon reasonable academic request.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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