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Clinical Trials in South Korea / NCT07816068
Starting soon Phase 4

Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery

NCT07816068 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Phase 4
Started
2026-10-01
Last updated
2026-09-17

Condition(s) studied

Aortic Aneurysm of the Proximal ArchAortic Aneurysms ArchAortic Arch DiseasePostoperative Delirium (POD)POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINEPostoperative Delirium

Investigational drug(s) / intervention(s)

Remimazolam Besylate →propofol →

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)

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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 \<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

Primary outcome measure(s)

  • Incidence of postoperative cognitive decline — 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.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07816068 on ClinicalTrials.gov ↗ ← All trials in South Korea