Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes of haemodynamics and heart rate variability parameters
研究概览
简要总结
Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients.
The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure and heart rate variability during drug infusion) depend on pre-drug autonomic system activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement before drug injection and during drug infusion. Heart rate and blood pressure measured before and during drug infusion will be analysed.
HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug injection and during its infusion. 5 minutes intervals will be analysed , using Frequency Domain Measures of HRV. Surgical procedure will start after measurement have been taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
- •planned eye surgery under sedation
排除标准
- •patient's refusal
- •contraindications to dexmedetomidine
- •diseases/drugs that influence on autonomic nervous system activity
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine, 1 mcg/kg over 10 minutes, followed by a maintenance infusion, given to achieve sedation for eye surgery procedure
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Changes of haemodynamics and heart rate variability parameters
时间窗: up to 30 minutes
次要结局
未报告次要终点
研究者
Magdalena Wujtewicz
M.D., Ph.D
Medical University of Gdansk