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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children going under sedation with propofol | Experimental | 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. |
|
| children not going under sedation | Active Comparator | A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memory test | Other |
| ||
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| 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). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Kelhoffer, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27938911 | Derived | Veselis R, Kelhoffer E, Mehta M, Root JC, Robinson F, Mason KP. Propofol sedation in children: sleep trumps amnesia. Sleep Med. 2016 Nov-Dec;27-28:115-120. doi: 10.1016/j.sleep.2016.10.002. Epub 2016 Oct 22. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | Posted | Count of Participants | Participants | 1 year |
|
AE data was collected on the day of treatment. There is no follow-up period.
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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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Kelhoffer, MD | Memorial Sloan Kettering Cancer Center | 212-639-8781 | kelhoffe@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2013 | Nov 20, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| Recognition task improperly completed |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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 | Hit rate | 1 year |
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|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |