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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time-weighted average (TWA) of the vasoactive-inotropic score (VIS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •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
研究组 & 干预措施
Propofol group
Propofol (20mg/mL)
干预措施: propofol (Drug)
Remimazolam group
Remimazolam Besylate (2mg/mL)
干预措施: Remimazolam Besylate (Drug)
结局指标
主要结局
Time-weighted average (TWA) of the vasoactive-inotropic score (VIS)
时间窗: From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min)
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-weighted average (TWA) of the vasoactive-inotropic score (VIS)
时间窗: 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.
次要结局
- Cumulative norepinephrine dosage(From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min))
- Peak VIS(From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 min))
- 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 min))
- Cumulative norepinephrine dosage(From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes))
- Peak VIS(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(From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes))
研究者
Youn Joung Cho, MD, PhD
Clinical Associate Professor
Seoul National University Hospital