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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
\- 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)
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)
Seoul National University Hospital
Seoul, South Korea
Incidence of postoperative cognitive decline
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.
Time frame: Preoperative baseline to postoperative day 7 or before hospital discharge
Change in plasma IL-1β concentration
Plasma interleukin-1 beta (IL-1β) concentration will be measured at preoperative baseline and 2-4 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma IL-1β concentration will be measured in pg/mL using the Meso Scale Discovery assay.
Time frame: Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
Change in plasma TNF-α concentration
Plasma tumor necrosis factor-alpha (TNF-α) concentration will be measured at preoperative baseline and 2-4 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma TNF-α concentration will be measured in pg/mL using the Meso Scale Discovery assay.
Time frame: Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
Change in plasma IL-6 concentration
Plasma interleukin-6 (IL-6) concentration will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma IL-6 concentration will be measured in pg/mL using the Meso Scale Discovery assay.
Time frame: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Change in plasma IL-10 concentration
Plasma interleukin-10 (IL-10) concentration will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma IL-10 concentration will be measured in pg/mL using the Meso Scale Discovery assay.
Time frame: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Change in plasma HMGB1 concentration
Plasma high mobility group box 1 (HMGB1) concentration will be measured at preoperative baseline, 2-4 hours after completion of cardiopulmonary bypass, and 24 hours after completion of cardiopulmonary bypass. Changes from baseline will be compared between the remimazolam and propofol groups. Plasma HMGB1 concentration will be measured in pg/mL using the Multiplex bead assay.
Time frame: Preoperative baseline through 24 hours after completion of cardiopulmonary bypass
Change in plasma GFAP concentration
Plasma glial fibrillary acidic protein (GFAP) concentration will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. GFAP will be analyzed using the Single Molecule Array (Simoa) assay.
Time frame: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
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