Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Paradoxical excitement response
研究概览
简要总结
- Adequate sedation with classical sedative agents, propofol
- Sedation with propofol may induce paradoxical excitement response in heavy alcohol drinkers
- Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol drinkers
详细描述
- Adequate sedation during surgery provide anxiolysis and comfort to patient. Insufficient sedation can't provide comfort to patient during surgery, otherwise excessive sedation can cause variable complications like respiratory depression or delayed awakening.
- Dexmedetomidine is a centrally acting α2 receptor agonist that is increasingly being used as a sedative for MAC and intensive care with mechanical ventilated patients because of its analgesic properties, "cooperative sedation," and lack of respiratory depression.
- Because of the different site of action between dexmedetomidine and propofol, we assumed that paradoxical excitement responses which appeared in heavy alcohol drinkers in midazolam or propofol-induced sedation might be less observed in dexmedetomidine-induced sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19~65 yr-old patients who is scheduled to undergo knee surgery with regional anesthesia
排除标准
- •History of taking anxiolytics, hypnotics, antiepileptic drugs
- •Abnormal liver function test (eg: Liver cirrhosis, elevated liver enzymes)
- •History of allergic reaction with dexmedetomidine or propofol
- •Contraindication with regional anesthesia
- •American society of anesthesiologist Physical status III or IV
研究组 & 干预措施
alcohol drinker & dexmedetomidine
dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery
干预措施: Dexmedetomidine (Drug)
alcohol drinker & propofol
Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
干预措施: Propofol (Drug)
Non-alcohol drinker & dexmedetomidine
dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery
干预措施: Dexmedetomidine (Drug)
Non-alcohol drinker & propofol
Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
干预措施: Propofol (Drug)
结局指标
主要结局
Paradoxical excitement response
时间窗: Every 5 minutes up to 120minutes after drug infusion
Paradoxical excitement responses (verbal/movement) 0, none : no excitement response 1. mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining 2. moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint 3. severe : agitation and spontaneous movements with a need to restrain the patient
次要结局
- OAA/S(Every 5minutes up to 120minutes after drug infusion)
- Vital signs(During operation)
研究者
Jeong-il Choi
Professor
Chonnam National University Hospital