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Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Sponsor: Seoul National University Hospital
Summary
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.
Official title: Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-10-01
Completion Date
2027-11-30
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
Remimazolam Besylate
\- Continuous drug: remimazolam diluted to 2 mg/mL in normal saline - Maintenance: 1-2 mg/kg/h (titrated to BIS 40-60, max 2 mg/kg/h)
propofol
Continuous drug: propofol (undiluted, 20 mg/mL) - Administration: target-controlled infusion (TCI, Marsh model) - Maintenance: 1-1.5 μg/mL (titrated to BIS 40-60)
Locations (1)
Seoul National University Hospital
Seoul, South Korea