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NCT07816068
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Conditions: Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch, Aortic Arch Disease, Postoperative Delirium (POD), POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, Postoperative Delirium
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Seoul National University Hospital
Location: Seoul National University Hospital Seoul
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Pre-existing cognitive impairment, defined as Mini-Mental State Examination (MMSE) score \
Source: ClinicalTrials.gov (NCT07816068). StuddyBuddy aggregates publicly available trial information.