Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- Incidence of hypotension
研究概览
简要总结
Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion.
This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •scheduled for elective surgery under general anesthesia
- •adult patient (over 19 years old)
- •American Society of Anesthesiology Physical Status I-III
排除标准
- •arrythmia
- •liver dysfunction
- •kidney dysfunction
- •uncontrolled hypertension
- •uncontrolled diabetes mellitus
- •allergic to benzodiazepines
- •heart failure
- •drug intoxication
- •alcohol intoxication
研究组 & 干预措施
Bolus
Anesthetic induction with bolus remimazolam administration
干预措施: Remimazolam bolus (Drug)
Continuous
Anesthetic induction with continuous remimazolam administration
干预措施: Remimazolam continuous (Drug)
结局指标
主要结局
Incidence of hypotension
时间窗: 10 minutes after anesthetic induction
Systolic pressure below 90 mmHg
次要结局
- Incidence of bradycardia(10 minutes after anesthetic induction)
- The lowest systolic blood pressure(10 minutes after anesthetic induction)
- Number of participants with vasoactive drug use(10 minutes after anesthetic induction)
- Time to loss of consciousness(10 minutes after anesthetic induction)
- Dosage of remimazolam(10 minutes after anesthetic induction)
研究者
Eunah Cho, MD
Assistant Professor
Kangbuk Samsung Hospital