Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Hemodynamic Instability During Anesthesia, Intraoperative Hypotension
Conditions
Keywords
Remimazolam, Propofol, Total intravenous anesthesia, TEVAR, EVAR, Endovascular aortic repair, Vasoactive-inotropic score, Norepinephrine, Hemodynamic stability
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.
Interventions
DRUGRemimazolam 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
DRUGpropofol
* 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)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average (TWA) of the vasoactive-inotropic score (VIS) | From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative norepinephrine dosage | From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes) | Cumulative norepinephrine dosage including bolus dose |
| Peak VIS | From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes) | Maximum VIS value recorded during the assessment period |
| 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) | Time-weighted average of cumulative norepinephrine usage including bolus dose |
Countries
South Korea
Contacts
CONTACTYoun Joung Cho, MD, PhD
Outcome results
None listed