Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy (RMZ-OLI-ENDO)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ling long Gong, PhD
- 电话号码：+86-17317107780
- 邮箱：350552970@qq.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200444
- 招聘中
- Shanghai Baoshan District Dachang Hospital (Renji Hospital Baoshan Branch)
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接触：
- Linglong Gong, MD
- 电话号码：+86-17317107780
- 邮箱：17317107780@163.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
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.
其他名称：
Administered intravenously before or during the procedure to provide stable analgesic cooperation and optimize procedural sedation quality in elderly patients.
其他名称：
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有源比较器：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of hypoxemia
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Hypotension
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月17日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年7月5日
首先提交符合 QC 标准的
2026年7月11日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月21日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-E-58 (其他赠款/资助编号：Shanghai Baoshan District Science and Technology Commission)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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