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Clinical Trials in South Korea / NCT07806006
Starting soon Phase 4

Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair

NCT07806006 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Phase 4
Started
2026-09-15
Last updated
2026-09-10

Condition(s) studied

Aortic Aneurysm, ThoracoabdominalAortic Aneurysm, AbdominalIntraoperative HypotensionHemodynamic Instability During Anesthesia

Investigational drug(s) / intervention(s)

Remimazolam Besylate →propofol →

Remimazolam Besylate: * Continuous drug: remimazolam diluted to 2 mg/mL in normal saline * Induction: 6 mg/kg/h continuous infusion * Maintenance: 1-2 mg/kg/h (titrated to PSI 25-50, max 2 mg/kg/h) * Reversal at end of procedure: flumazenil 0.2-0.5 mg

propofol: * Continuous drug: propofol (undiluted, 20 mg/mL) * Administration: target-controlled infusion (TCI, Marsh model) * Induction: effect-site target concentration 4 μg/mL * Maintenance: 2-4 μg/mL (titrated to PSI 25-50)

Study summary

The purpose of this study is to compare two intravenous anesthetics, remimazolam and propofol, for their effects on intraoperative hemodynamic stability in patients undergoing thoracic or abdominal endovascular aortic repair. Maintaining blood pressure during these procedures is important to preserve organ perfusion, yet anesthetic-induced hypotension often requires vasopressor support. Since direct comparisons of these two anesthetics on hemodynamic outcomes in this population are limited, this randomized, single-blind, controlled trial will compare the intraoperative vasopressor requirement between the two groups to provide evidence for selecting a more hemodynamically stable anesthetic in these high-risk patients.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: \- Adults aged 20 years or older scheduled for thoracic or abdominal endovascular aortic repair (TEVAR/EVAR) under general anesthesia for thoracic or abdominal aortic aneurysm Exclusion Criteria: * Known or suspected allergy or hypersensitivity to the study drugs * ASA physical status class IV or higher * Body mass index (BMI) ≥ 30 kg/m\^2 * Chronic use of opioids or benzodiazepines * History of alcohol or drug abuse * Preoperative cognitive impairment * Severe left ventricular dysfunction (left ventricular ejection fraction \< 40%) * Severe hepatic dysfunction (Child-Pugh class C) * Severe hypoalbuminemia (\< 2.0 g/dL) * Acute or chronic renal failure requiring dialysis * Pregnancy or breastfeeding * Emergency procedure

Primary outcome measure(s)

  • Time-weighted average (TWA) of the vasoactive-inotropic score (VIS) — From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
    Time-weighted average (TWA) of the vasoactive-inotropic score (VIS), calculated from the start of anesthetic administration to the start of hemostasis at the femoral access site. VIS reflects the cumulative dose of vasoactive and inotropic agents used to maintain target blood pressure during the procedure.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07806006 on ClinicalTrials.gov ↗ ← All trials in South Korea