Aortic Aneurysm, ThoracoabdominalPhase 4NCT07806006
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
A Phase 4 study testing Remimazolam Besylate and propofol in people with Aortic Aneurysm, Thoracoabdominal and Aortic Aneurysm, Abdominal, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal, Intraoperative Hypotension
- What is being tested?
- Remimazolam Besylate and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2026to 30 Oct 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Youn Joung Cho, MD, PhD, 82-2-2072-3108, mingming7@gmail.com
About this study
Official 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
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
- Being tested
- Remimazolam Besylate, propofol
- Keywords
- Remimazolam, Propofol, Total intravenous anesthesia, TEVAR, EVAR, Endovascular aortic repair, Vasoactive-inotropic score, Norepinephrine, Hemodynamic stability
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
- 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
propofolDrug
- 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 group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Remimazolam Besylate (2mg/mL) Receives: Drug: Remimazolam Besylate |
| Propofol group | Experimental | Propofol (20mg/mL) Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Cumulative norepinephrine dosage including bolus dose
Measured: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
Peak VIS
Maximum VIS value recorded during the assessment period
Measured: 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
Time-weighted average of cumulative norepinephrine usage including bolus dose
Measured: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracoabdominalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806006
- Sponsor's protocol ID
- (T)EVAR_RMZ vs PPF
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided