A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 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 determine the effects of dexmedetomidine on memory and recall of children who are receiving dexmedetomidine sedation administered for magnetic resonance imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in children has not been studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 Dexmedetomidine (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 undergoing sedation with Dexmedetomidine
Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction 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 dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
Children undergoing sedation with Dexmedetomidine
Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction 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 dexmedetomidine.
干预措施: Memory Test (Other)
Children not undergoing sedation
A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.
干预措施: Memory Test (Other)
结局指标
主要结局
Sedation Threshold
时间窗: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
During the 10-minute bolus infusion of Dexmedetomidine, 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(Until 100 cards have been presented to the child. Approx. 10 minutes.)
研究者
Keira Mason
Keira Mason, MD
Boston Children's Hospital