Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of hypoxemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •Mini-Mental State Examination (MMSE) score ≥
- •Provision of written informed consent by the patient or legal representative.
排除标准
- •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 ≥
- •Use of sedative or analgesic drugs within 24 hours before enrollment.
研究组 & 干预措施
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.
干预措施: Remimazolam Tosilate for Injection (Drug)
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.
干预措施: Remimazolam Tosilate for Injection (Drug)
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.
干预措施: Oliceridine Fumarate (Drug)
结局指标
主要结局
Incidence of hypoxemia
时间窗: From initiation of sedation induction to completion of the gastrointestinal endoscopic procedure, approximately 30 minutes.
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.
次要结局
- Incidence of Hypotension(From the pre-induction baseline assessment to transfer to the post-anesthesia care unit, up to 1 hour.)
- Sedation success rate(From the start of sedation induction to the completion of the endoscopic procedure)