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NCT Number: NCT07816068

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

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.

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Key information

Conditions

Aortic Aneurysm of the Proximal Arch Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Aneurysms Arch Aortic Arch Disease Aortic Diseases Cardiovascular Diseases Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Postoperative Delirium (POD) Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam besylate

Drug
  • 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

Drug

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in plasma neuroinflammatory and neuronal injury biomarkers

    Time frame: Preoperative baseline through 24 hours after completion of cardiopulmonary bypass

    Plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-10), the neuroinflammatory mediator high mobility group box 1 (HMGB1), and the neuronal injury biomarker glial fibrillary acidic protein (GFAP) will be measured and compared between the remimazolam and propofol groups. IL-1β and TNF-α will be measured at preoperative baseline and 2-4 hours after completion of cardiopulmonary bypass; IL-6, IL-10, and GFAP will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass; and HMGB1 will be measured at preoperative baseline, 2-4 hours, and 24 hours after completion of cardiopulmonary bypass. Changes in biomarker concentrations over time will be compared between the two groups.

Other outcomes

  1. Incidence of postoperative delirium

    Time frame: Preoperative baseline to postoperative day 7 or before hospital discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Youn Joung Cho, M.D., Ph.D.

CONTACT

[email protected]

82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hana Pharm Co., Ltd.

Registry information

Official study title

Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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