Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of postoperative cognitive decline
研究概览
简要总结
The purpose of this study is to compare remimazolam- and propofol-based anesthesia for their effects on postoperative cognitive dysfunction in patients undergoing aortic arch surgery. These procedures involve a substantial risk of cerebral ischemia and reperfusion injury, which may contribute to postoperative cognitive decline. Although experimental studies have suggested potential neuroprotective effects of remimazolam, clinical evidence in patients undergoing high-risk aortic arch surgery remains limited. This prospective, randomized controlled trial will compare the incidence of postoperative cognitive dysfunction between patients receiving remimazolam- or propofol-based anesthesia. In addition, changes in circulating neuroinflammatory and neuronal injury biomarkers will be evaluated to explore the potential mechanisms underlying any neuroprotective effect of remimazolam. The findings may provide clinical evidence to guide anesthetic selection and improve neurological outcomes in patients undergoing aortic arch surgery.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients scheduled to undergo total or partial aortic arch replacement for aortic arch disease, with planned circulatory arrest and/or selective cerebral perfusion as a cerebral protection strategy during surgery
排除标准
- •Pre-existing cognitive impairment, defined as Mini-Mental State Examination (MMSE) score <24
- •Acute cerebral hemorrhage or cerebral infarction within the previous 3 months
- •History of hypersensitivity to remimazolam or other benzodiazepines
- •History of alcohol or substance abuse
- •Chronic use of opioids or benzodiazepines
- •Severe hepatic impairment (Child-Pugh class C)
- •Acute or chronic renal failure requiring dialysis Emergency surgery or acute aortic dissection
研究组 & 干预措施
Remimazolam group
Remimazolam Besylate (2mg/mL)
干预措施: Remimazolam Besylate (Drug)
Propofol group
Propofol (20mg/mL)
干预措施: propofol (Drug)
结局指标
主要结局
Incidence of postoperative cognitive decline
时间窗: Preoperative baseline to postoperative day 7 or before hospital discharge
Postoperative cognitive function will be assessed using the Korean Mini-Mental State Examination (K-MMSE) and the Korean version of the Montreal Cognitive Assessment (MoCA-K). Both assessments will be performed preoperatively and again on postoperative day 7 or before hospital discharge. Postoperative cognitive dysfunction will be defined as a decrease of ≥2 points from the preoperative baseline score in either the K-MMSE or MoCA-K.
次要结局
- Changes in plasma neuroinflammatory and neuronal injury biomarkers(Preoperative baseline through 24 hours after completion of cardiopulmonary bypass)
- Change in plasma IL-1β concentration(Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass)
- Change in plasma TNF-α concentration(Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass)
- Change in plasma IL-6 concentration(Preoperative baseline to 24 hours after completion of cardiopulmonary bypass)
- Change in plasma IL-10 concentration(Preoperative baseline to 24 hours after completion of cardiopulmonary bypass)
- Change in plasma HMGB1 concentration(Preoperative baseline through 24 hours after completion of cardiopulmonary bypass)
- Change in plasma GFAP concentration(Preoperative baseline to 24 hours after completion of cardiopulmonary bypass)
研究者
Youn Joung Cho, MD, PhD
Clinical Associate Professor
Seoul National University Hospital