A Phase 4 interventional study of Remimazolam Besylate and propofol in Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal and Intraoperative Hypotension, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 44 is below the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remimazolam Besylate (2mg/mL)
Drug: Remimazolam Besylate
Propofol (20mg/mL)
Drug: propofol
* 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
* 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)
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.
Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
Cumulative norepinephrine dosage
Cumulative norepinephrine dosage including bolus dose
Time frame: 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
Time frame: 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
Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
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 minutes)
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 minutes)
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 (minutes and mmHg·minutes)
Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
Average amount of remimazolam, propofol, and remifentanil used (mg/kg/hr, µg/kg/min, µg/kg/min, respectively)
Average amount of remimazolam, propofol, and remifentanil used (milligrams per kilogram per hour, micrograms per kilogram per minute, and micrograms per kilogram per minute, respectively)
Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
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 minutes)
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 minutes)
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 minutes)
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 minutes)
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 minutes)
Incidence of bradycardia (<45 beats per minute) requiring treatment
Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
Time to loss of consciousness
Time frame: From the start of anesthetic administration to loss of consciousness (intraoperative, up to 30 minutes)
Time to reaching Patient State Index (PSI) <=50
Time frame: From the start of anesthetic administration to the first Patient State Index ≤50 (intraoperative, up to 30 minutes)
Time to start norepinephrine continuous infusion
Time frame: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)
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
Length of hospital stay after the procedure
Time frame: 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
Time frame: within 24 hours postoperatively
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 minutes)
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
Incidence of postoperative delirium requiring pharmacological management (or clinical intervention)
Time frame: From the end of procedure to discharge, assessed up to 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Remimazolam besilate · Propofol
Aortic Aneurysm, Thoracoabdominal →
Seoul National University Hospital →