Dexmedetomidine, Memory
Conditions
Brief summary
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.
Interventions
DRUGDexmedetomidine
OTHERMemory Test
Sponsors
Memorial Sloan Kettering Cancer Center
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Threshold | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory Threshold | Until 100 cards have been presented to the child. Approx. 10 minutes. | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 16 |
| Total | 46 |
Baseline characteristics
| Characteristic | Children Not Undergoing Sedation | Children Undergoing Sedation With Dexmedetomidine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 30 Participants | 46 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.5 years STANDARD_DEVIATION 1.9 | 6.1 years STANDARD_DEVIATION 1.2 | 7.7 years STANDARD_DEVIATION 2.2 |
| Region of Enrollment United States | 16 Participants | 30 Participants | 46 Participants |
| Sex: Female, Male Female | 8 Participants | 22 Participants | 30 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 20 |
| serious Total, serious adverse events | 0 / 64 | 0 / 20 |
Outcome results
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.
Time frame: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children Undergoing Sedation With Dexmedetomidine | Sedation Threshold | 26.8 Number of Memory Cards | Standard Deviation 7.9 |
| Children Not Undergoing Sedation | Sedation Threshold | 38.9 Number of Memory Cards | Standard Deviation 5.9 |
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)
Time frame: Until 100 cards have been presented to the child. Approx. 10 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children Undergoing Sedation With Dexmedetomidine | Memory Threshold | 35.1 Number of Memory Cards seen before scan | Standard Deviation 6.6 |
| Children Not Undergoing Sedation | Memory Threshold | 50 Number of Memory Cards seen before scan | Standard Deviation 0 |