Aortic Aneurysm of the Proximal ArchPhase 4NCT07816068
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
A Phase 4 study testing Remimazolam Besylate and propofol in people with Aortic Aneurysm of the Proximal Arch and Aortic Aneurysms Arch, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch, Aortic Arch Disease
- What is being tested?
- Remimazolam Besylate and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2026to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Youn Joung Cho, MD. PhD., 82-2-2072-3108, mingming7@gmail.com
About this study
Official title: Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery: A Randomized Controlled Trial
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.
- Conditions
- Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch, Aortic Arch Disease, Postoperative Delirium (POD), POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, Postoperative Delirium
- Being tested
- Remimazolam Besylate, propofol
- Keywords
- Remimazolam, Propofol, Arch surgery, Arch disease, postoperative delirium, POCD (postoperative clinical decline)
- Medical subject headings
- Aneurysm, Aortic Arch, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
- 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)
propofolDrug
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 group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Remimazolam Besylate (2mg/mL) Receives: Drug: Remimazolam Besylate |
| Propofol group | Experimental | Propofol (20mg/mL) Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline to postoperative day 7 or before hospital discharge
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm of the Proximal ArchStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816068
- Sponsor's protocol ID
- Arch_RMZ vs PPF
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07816068
- Acronym / sponsor ID
- Arch_RMZ vs PPF
- Conditions
- Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch, Aortic Arch Disease, Postoperative Delirium (POD), POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, Postoperative Delirium
- Keywords
- Remimazolam, Propofol, Arch surgery, Arch disease, postoperative delirium, POCD (postoperative clinical decline)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolam BesylateRemimazolam Besylate (2mg/mL) |
| Propofol group | Experimental | Drug: propofolPropofol (20mg/mL) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Remimazolam group |
| propofolContinuous drug: propofol (undiluted, 20 mg/mL) - Administration: target-controlled infusion (TCI, Marsh model) - Maintenance: 1-1.5 μg/mL (titrated to BIS 40-60) | Drug | Propofol group |
Primary outcome
Incidence of postoperative cognitive decline
Time frame: 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.
6 secondary outcomes
Change in plasma IL-1β concentration
Time frame: Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
Change in plasma TNF-α concentration
Time frame: Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
Change in plasma IL-6 concentration
Time frame: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Change in plasma IL-10 concentration
Time frame: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Change in plasma HMGB1 concentration
Time frame: Preoperative baseline through 24 hours after completion of cardiopulmonary bypass
Change in plasma GFAP concentration
Time frame: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam Besylate and propofol in people with Aortic Aneurysm of the Proximal Arch and Aortic Aneurysms Arch, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youn Joung Cho, M.D., Ph.D. (82-2-2072-2467, mingming7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cognitive decline (time frame: Preoperative baseline to postoperative day 7 or before hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.