Amnesic Properties of Propofol, Pediatric Pateints
Conditions
Keywords
Amnesic, Propofol, 12-006
Brief summary
The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting.
Interventions
OTHERmemory test
DRUGPropofol
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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 propofol (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 | 1 year | During the 10-minute infusion of propofol, 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 | 1 year | 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 Going Under Sedation With Propofol Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion 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 propofol.
measure the amnesic effects of propofol.
memory test
Propofol | 30 |
| Children Not Going Under Sedation A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test | 20 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not Treated | 1 | 0 |
| Overall Study | Recognition task improperly completed | 7 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 0 |
Baseline characteristics
| Characteristic | Children Going Under Sedation With Propofol | Total | Children Not Going Under Sedation |
|---|---|---|---|
| Age, Continuous | 6.2 years | 7.2 years | 8.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 44 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 44 Participants | 18 Participants |
| Region of Enrollment United States | 30 Participants | 50 Participants | 20 Participants |
| Sex: Female, Male Female | 14 Participants | 25 Participants | 11 Participants |
| Sex: Female, Male Male | 16 Participants | 25 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 20 |
| other Total, other adverse events | 0 / 30 | 0 / 20 |
| serious Total, serious adverse events | 0 / 30 | 0 / 20 |
Outcome results
Primary
Sedation Threshold
During the 10-minute infusion of propofol, 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: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Children Going Under Sedation With Propofol | Sedation Threshold | Memory Lost w/in 2 minutes of sedation | 29 Participants |
| Children Going Under Sedation With Propofol | Sedation Threshold | No memory loss w/in 2 minutes of sedation | 1 Participants |
| Children Not Going Under Sedation | Sedation Threshold | Memory Lost w/in 2 minutes of sedation | NA Participants |
| Children Not Going Under Sedation | Sedation Threshold | No memory loss w/in 2 minutes of sedation | 0 Participants |
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: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children Going Under Sedation With Propofol | Memory Threshold | 0.71 Hit rate | Standard Deviation 0.16 |
| Children Not Going Under Sedation | Memory Threshold | 0.93 Hit rate | Standard Deviation 0.06 |