A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients
2018年10月24日 更新者：Keira Mason、Boston Children's Hospital
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.
研究概览
研究类型
观察性的
注册 (实际的)
84
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Boston Children's Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4年 至 14年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Children between the ages of 4 and 14 years old either requiring sedation or attempting without sedation for MRI imaging will be offered inclusion in the study.
Sedation will be administered per established and approved BCH sedation guidelines: over 10 minutes, a bolus of 2 mcg/kg of dexmedetomidine will be administered intravenously.
The sedation process will not change for this study.
During the bolus, pictures will be shown to the child who will be encouraged to name the item in the picture.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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.
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其他名称：
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Children not undergoing sedation
A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sedation Threshold
大体时间：Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
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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.
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Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Memory Threshold
大体时间：Until 100 cards have been presented to the child. Approx. 10 minutes.
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At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously.
Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives)
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Until 100 cards have been presented to the child. Approx. 10 minutes.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Keira Mason, MD、Boston Children's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2015年1月29日
首先提交符合 QC 标准的
2015年1月29日
首次发布 (估计)
2015年2月3日
研究记录更新
最后更新发布 (实际的)
2019年2月28日
上次提交的符合 QC 标准的更新
2018年10月24日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.