A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT02278003|
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Pateints Amnesic Properties of Propofol||Other: memory test Drug: Propofol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 10, 2017|
|Actual Study Completion Date :||May 10, 2017|
Experimental: 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.
Other: memory test
Active Comparator: 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.
Other: memory test
- Sedation Threshold [ Time Frame: 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.
- Memory Threshold [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278003
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Eric Kelhoffer, MD||Memorial Sloan Kettering Cancer Center|