Comparison of the Incidence of Hypotension With Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The incidence of hypotension
研究概览
简要总结
Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients with age over 60 years old
- •scheduled for elective surgery under general anesthesia
- •American Society of Anesthesiology Physical Status I-III
排除标准
- •Arrhythmia
- •Liver dysfunction
- •Kidney dysfunction
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus
- •Allergic to benzodiazepines
- •Heart failure
- •Drug intoxication
- •Alcoholics
- •Cognitive dysfunction
- •Unable to understand and consent voluntarily
研究组 & 干预措施
Bolus
Remimazolam bolus injection for 20 seconds
干预措施: Bolus of remimazolam (Drug)
Continuous
Remimazolam continuous infusion
干预措施: Continuous infusion of remimazolam (Drug)
结局指标
主要结局
The incidence of hypotension
时间窗: 10 minutes after intubation
Systolic blood pressure \< 90 mmHg
次要结局
- The incidence of bradycardia(10 minutes after intubation)
- Number of participants with use of any vasopressors(10 minutes after intubation)
- Lowest systolic blood pressure(10 minutes after intubation)
- Time to loss of consciousness(10 minutes after intubation)
- Total remimazolam used for anesthetic induction(10 minutes after intubation)
研究者
Eunah Cho, MD
Assistant Professor
Kangbuk Samsung Hospital