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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Keira Mason, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28100530 | Derived | Mason KP, Kelhoffer ER, Prescilla R, Mehta M, Root JC, Young VJ, Robinson F, Veselis RA. Feasibility of measuring memory response to increasing dexmedetomidine sedation in children. Br J Anaesth. 2017 Feb;118(2):254-263. doi: 10.1093/bja/aew421. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dexmedetomidine Memory Test |
| FG001 | Children Not Undergoing Sedation | A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dexmedetomidine Memory Test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Number of Memory Cards | Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Dexmedetomidine Memory Test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keira Mason, MD | Boston Children's Hospital | 6173552339 | keira.mason@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Memory Test |
| Other |
|
| BG001 | Children Not Undergoing Sedation | A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Children Not Undergoing Sedation | A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test |
|
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| Secondary | 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) | Posted | Mean | Standard Deviation | Number of Memory Cards seen before scan | Until 100 cards have been presented to the child. Approx. 10 minutes. |
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|
|
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Children Not Undergoing Sedation | A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test | 0 | 20 | 0 | 20 |
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