Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Time to Sedation Score of 3-4
研究概览
简要总结
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a muscle biopsy for IRB11-00203.
排除标准
- 未提供
研究组 & 干预措施
Dexmedetomidine 1 mcg/kg
Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
干预措施: Ketamine (Drug)
Dexmedetomidine 1 mcg/kg
Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.5 mcg/kg
Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
干预措施: Ketamine (Drug)
Dexmedetomidine 0.5 mcg/kg
Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Time to Sedation Score of 3-4
时间窗: Immediately prior to incision
The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.
次要结局
- Heart Rate Change After Dexmedetomidine Loading Dose(Baseline to immediately post dexmedetomidine infusion.)
- Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose(Baseline to immediately post dexmedetomidine infusion.)
- Oxygen Saturation Change After Dexmedetomidine Loading Dose(Baseline to immediately post dexmedetomidine infusion.)
- EtCO2 Change After Dexmedetomidine Loading Dose(Baseline to immediately post dexmedetomidine infusion.)
研究者
Joseph D. Tobias
Chairman, Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital