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NCT Number: NCT07806006

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

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.

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Key information

Conditions

Aortic Aneurysm, Thoracoabdominal Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Hemodynamic Instability During Anesthesia Intraoperative Hypotension Vascular Diseases

Age range

20 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 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

Treatment and study plan

Remimazolam besylate

Drug
  • 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

Drug
  • 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)

Primary outcomes

  1. Time-weighted average (TWA) of the vasoactive-inotropic score (VIS)

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

    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.

Secondary outcomes

  1. Cumulative norepinephrine dosage

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

    Cumulative norepinephrine dosage including bolus dose

  2. Peak VIS

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

    Maximum VIS value recorded during the assessment period

  3. Time-weighted average of cumulative norepinephrine usage

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

    Time-weighted average of cumulative norepinephrine usage including bolus dose

Other outcomes

  1. Time-weighted average patient state index (PSI) during the procedure

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  2. Time-weighted average intraoperative mean arterial pressure

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  3. Duration and area under the curve (AUC) out of target mean arterial pressure range

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

    Duration and area under the curve (AUC) out of target mean arterial pressure range (min and mmHg*min)

  4. Average amount of remimazolam, propofol, and remifentanil used (mg/kg/hr, µg/kg/min, µg/kg/min, respectively)

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  5. Incidence and severity of unintended patient movement or spontaneous breathing during general anesthesia (graded as minor, transient surgical interruption, or leading to patient complications)

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  6. Frequency and total dose of bolus administration of vasoactive-inotropic agents (including norepinephrine)

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  7. Time-weighted average usage of vasopressors or inotropes, other than norepinephrine

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  8. Weight-adjusted fluid used (crystalloids and colloids, separately)

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  9. Incidence of blood transfusion, type of blood products, and units transfused

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  10. Incidence of bradycardia (<45 beats/min) requiring treatment

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  11. Time to loss of consciousness

    Time frame: From the start of anesthetic administration to loss of consciousness, up to 30 min

  12. Time to reaching Patient State Index (PSI) <=50

    Time frame: From the start of anesthetic administration to loss of consciousness, up to 30 min

  13. Time to start norepinephrine continuos infusion

    Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  14. Length of stay in the intensive care unit or recovery room after the procedure

    Time frame: From the end of procedure to ICU/recovery room discharge, assessed up to 30 days

  15. Length of hospital stay after the procedure

    Time frame: From the end of procedure to hospital discharge, assessed up to 30 days

  16. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: within 24 hours postoperatively

    Incidence of postoperative nausea and vomiting (PONV), including nausea, vomiting, and requirement for rescue antiemetics, within 24 hours postoperatively

  17. Time-weighted average QTc (corrected QT) interval and its change from baseline

    Time frame: From the anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

  18. Postoperative opioid consumption, expressed as oral (or intravenous) morphine milligram equivalents (MME)

    Time frame: From the end of procedure to discharge, assessed up to 7 days

  19. Incidence of postoperative delirium requiring pharmacological management (or clinical intervention)

    Time frame: From the end of procedure to discharge, assessed up to 7 days

Study contacts

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

Youn Joung Cho, MD, PhD

CONTACT

[email protected]

82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair: A Randomized, Single-blind, Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 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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