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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal; Intraoperative Hypotension; Hemodynamic Instability During Anesthesia
• Intervention / Treatment: Drug: Remimazolam Besylate; Drug: propofol

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Youn Joung Cho, MD, PhD; Phone Number: 82-2-2072-2467; Email: mingming7@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
    • Contact: Youn Joung Cho, MD, PhD; Phone Number: 82-2-2072-3108; Email: mingming7@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam group; Remimazolam Besylate (2mg/mL)	Drug: 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
Experimental: Propofol group; Propofol (20mg/mL)	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative norepinephrine dosage	Cumulative norepinephrine dosage including bolus dose	From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Peak VIS	Maximum VIS value recorded during the assessment period	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	Time-weighted average of cumulative norepinephrine usage including bolus dose	From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 min)
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 min)
Duration and area under the curve (AUC) out of target mean arterial pressure range	Duration and area under the curve (AUC) out of target mean arterial pressure range (min and mmHg*min)	From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Average amount of remimazolam, propofol, and remifentanil used (mg/kg/hr, µg/kg/min, µg/kg/min, respectively)		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Incidence and severity of unintended patient movement or spontaneous breathing during general anesthesia (graded as minor, transient surgical interruption, or leading to patient complications)		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Frequency and total dose of bolus administration of vasoactive-inotropic agents (including norepinephrine)		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Time-weighted average usage of vasopressors or inotropes, other than norepinephrine		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Weight-adjusted fluid used (crystalloids and colloids, separately)		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Incidence of blood transfusion, type of blood products, and units transfused		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Incidence of bradycardia (<45 beats/min) requiring treatment		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Time to loss of consciousness		From the start of anesthetic administration to loss of consciousness, up to 30 min
Time to reaching Patient State Index (PSI) <=50		From the start of anesthetic administration to loss of consciousness, up to 30 min
Time to start norepinephrine continuos infusion		From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Length of stay in the intensive care unit or recovery room after the procedure		From the end of procedure to ICU/recovery room discharge, assessed up to 30 days
Length of hospital stay after the procedure		From the end of procedure to hospital discharge, assessed up to 30 days
Incidence of postoperative nausea and vomiting (PONV)	Incidence of postoperative nausea and vomiting (PONV), including nausea, vomiting, and requirement for rescue antiemetics, within 24 hours postoperatively	within 24 hours postoperatively
Time-weighted average QTc (corrected QT) interval and its change from baseline		From the anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
Postoperative opioid consumption, expressed as oral (or intravenous) morphine milligram equivalents (MME)		From the end of procedure to discharge, assessed up to 7 days
Incidence of postoperative delirium requiring pharmacological management (or clinical intervention)		From the end of procedure to discharge, assessed up to 7 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Propofol; Norepinephrine; Hemodynamic stability; TEVAR; EVAR; Endovascular aortic repair; Remimazolam; Total intravenous anesthesia; Vasoactive-inotropic score
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Abdominal; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol
• Other Study ID Numbers: (T)EVAR_RMZ vs PPF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No