A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Sedation Threshold
研究概览
简要总结
The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation
- •The patient must be able to comprehend and perform the task (naming pictures)
- •The patient must have a minimum weight of 8 kg
排除标准
- •Allergy to propofol (for those patients requiring sedation)
- •Procedure of short duration (< 15 min)
- •Pregnancy
- •Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)
研究组 & 干预措施
children going under sedation with propofol
Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.
measure the amnesic effects of propofol.
干预措施: memory test (Other)
children going under sedation with propofol
Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol.
measure the amnesic effects of propofol.
干预措施: Propofol (Drug)
children not going under sedation
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
干预措施: memory test (Other)
结局指标
主要结局
Sedation Threshold
时间窗: 1 year
During the 10-minute infusion of propofol, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.
次要结局
- Memory Threshold(1 year)