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

NCT07806006 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: (T)EVAR_RMZ vs PPF
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Abdominal; Intraoperative Hypotension; Hemodynamic Instability During Anesthesia

Keywords

Remimazolam; Propofol; Total intravenous anesthesia; TEVAR; EVAR; Endovascular aortic repair; Vasoactive-inotropic score; Norepinephrine; Hemodynamic stability

Outcome Measures

Primary Outcomes (1)

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

  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.

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

Secondary Outcomes (3)

• Cumulative norepinephrine dosage

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

• Peak VIS

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

• Time-weighted average of cumulative norepinephrine usage

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

Other Outcomes (19)

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

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

• Time-weighted average intraoperative mean arterial pressure

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

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

  From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Remimazolam Besylate (2mg/mL)

Drug: Remimazolam Besylate

Propofol group

EXPERIMENTAL

Propofol (20mg/mL)

Drug: propofol

Interventions

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)

Propofol group

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

Remimazolam group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Abdominal

Interventions

Propofol

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Youn Joung Cho, MD, PhD

CONTACT

82-2-2072-2467; mingming7@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: September 8, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

KR (1)