Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Total Consumption of Remimazolam
研究概览
简要总结
The purpose of this prospective randomized controlled trial is to compare the total consumption of remimazolam between two different administration methods-Target-Controlled Infusion (TCI) and manual infusion-in patients undergoing cerebrovascular bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo cerebrovascular bypass surgery under general anesthesia.
- •American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
- •Adults aged 19 years or older
- •Patients who have provided prior written informed consent to participate in the study
排除标准
- •Patients who do not consent to participate in the research
- •Patients classified as ASA Physical Status 4
- •Patients with a BMI ≤18.5 kg/m2 or 35.0 ≥ kg/m2
- •History of allergy to benzodiazepine-class medications
- •Patients with acute narrow-angle glaucoma
- •Patients in a state of shock or coma
- •Acute alcohol intoxication with suppressed vital signs , or patients with alcohol or drug dependency
- •Presence of Sleep Apnea Syndrome or severe/acute respiratory failure
- •Patients with lactose intolerance or hypersensitivity to Dextran 40
研究组 & 干预措施
TCI
Remimazolam administered via TCI (target Ce 0.7 μg/mL)
干预措施: Target-Controlled Infusion (TCI) of Remimazolam (Other)
Manual Infusion
Remimazolam administered via manual infusion (6 mg/kg/hr for induction, 1-2 mg/kg/hr for maintenance)
干预措施: Manual Infusion of Remimazolam (Other)
结局指标
主要结局
Total Consumption of Remimazolam
时间窗: From the start of anesthesia induction to the end of surgery (intraoperative period).
The total cumulative dose of remimazolam ($mg$) administered from the initiation of anesthesia induction until the completion of the surgical procedure.
次要结局
未报告次要终点
研究者
Chang-Hoon Koo
Associate professor
Seoul National University Hospital