About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Known or suspected allergy or hypersensitivity to the study drugs
ASA physical status class IV or higher
Body mass index (BMI) ≥ 30 kg/m²
Chronic use of opioids or benzodiazepines
Trial design
Parallel
Treatments tested in this trial
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
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)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Cumulative norepinephrine dosage
Cumulative norepinephrine dosage including bolus dose
Peak VIS
Maximum VIS value recorded during the assessment period
Time-weighted average of cumulative norepinephrine usage
Time-weighted average of cumulative norepinephrine usage including bolus dose
Other outcomes
Time-weighted average patient state index (PSI) during the procedure
Time-weighted average intraoperative mean arterial pressure
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)
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)
Sponsors and contacts
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