A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients

Conditions
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Memory, Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: Memory Test


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children undergoing sedation with Dexmedetomidine<br>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. | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;Other: Memory Test<br> <br> |
| Children not undergoing sedation<br>A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. | Other: Memory Test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Threshold | 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. | Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory Threshold | 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) | Until 100 cards have been presented to the child. Approx. 10 minutes. |