A Phase 4 interventional study of Remimazolam Besylate and propofol in Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch and Aortic Arch Disease, sponsored by Seoul National University Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
27 studies on the registry are indexed under Aneurysm, Aortic Arch; 14 are open to participants now.
This study's planned enrollment of 80 is below the median of 115 across 19 interventional studies indexed under Aneurysm, Aortic Arch.
Browse Aneurysm, Aortic Arch studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remimazolam Besylate (2mg/mL)
Drug: Remimazolam Besylate
Propofol (20mg/mL)
Drug: propofol
\- 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)
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
Incidence of postoperative delirium
Postoperative delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The incidence of postoperative delirium will be compared between the remimazolam and propofol groups.
Time frame: Preoperative baseline to postoperative day 7 or before hospital discharge
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: start Oct 2026 → Nov 2026, primary completion Oct 2027 → Nov 2027 and completion Nov 2027 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Remimazolam besilate · Propofol
Seoul National University Hospital →