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

14. september 2026 opdateret af: Youn Joung Cho, MD, PhD, Seoul National University Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Remimazolam group
Remimazolam Besylate (2mg/mL)
Medicin: 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)
Eksperimentel: Propofol group
Propofol (20mg/mL)
Medicin: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of postoperative cognitive decline
Tidsramme: 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.
Preoperative baseline to postoperative day 7 or before hospital discharge

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in plasma IL-1β concentration
Tidsramme: Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
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.
Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
Change in plasma TNF-α concentration
Tidsramme: Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
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.
Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass
Change in plasma IL-6 concentration
Tidsramme: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
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.
Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Change in plasma IL-10 concentration
Tidsramme: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
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.
Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
Change in plasma HMGB1 concentration
Tidsramme: Preoperative baseline through 24 hours after completion of cardiopulmonary bypass
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.
Preoperative baseline through 24 hours after completion of cardiopulmonary bypass
Change in plasma GFAP concentration
Tidsramme: Preoperative baseline to 24 hours after completion of cardiopulmonary bypass
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.
Preoperative baseline to 24 hours after completion of cardiopulmonary bypass

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of postoperative delirium
Tidsramme: 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.
Preoperative baseline to postoperative day 7 or before hospital discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Samarbejdspartnere

Hana Pharm Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

7. september 2026

Først indsendt, der opfyldte QC-kriterier

7. september 2026

Først opslået (Faktiske)

11. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Arch_RMZ vs PPF

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