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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorSeoul National University Hospital

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 volunteers

Qualifiers

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

Design model

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

44 Participants
are divided into 2 treatment groups
Group A: Remimazolam groupExperimental treatment 1 intervention
Group B: Propofol groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

1

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)
2

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)
3

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)
4

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: