Cognitive Effects of Anesthesia on Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02005185|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : December 18, 2018
|Condition or disease|
|Procedures Requiring Anesthesia|
If the subject enrolls in the study, the child will undergo testing for 1) memory, 2) general brain function (i.e. intelligence testing). The parent will complete 3) a parental assessment of the subject's behavior through a standardized questionnaire.
Initial testing of all case and control participants will include an assessment for neurologic and psychiatric conditions, including attention deficit or learning disorders. In addition, each participant will be assessed by the Wechsler Abbreviated Scale of Intelligence (WASI) and the Child Behavioral Checklist (CBCL), which measures children's psychological well-being, competencies and behavioral/emotional problems.
After explaining the study to your child, we will show your child 80 items on a computer screen with a colored border in either in red, green, blue, or yellow. Following a short break, we will show your child 160 items on the screen. Half of these items were previously displayed and half of these items are new. We will ask your child two or three questions: Have we shown you this item before?How sure are you about your response? Your child will be given the choice of one of three categories: Very sure / halfway sure / not sure. What color was it? This question will only be asked if the answer to question 1 was yes.This portion of the test takes about 30 min. Subjects will then participate in a similar test of picture recognition, but we will ask about the location of the original image instead of the color. Your child will then be given a standardized intelligence test. This takes roughly 45 min to an hour to complete.
Some test participants will partake in a reading portion where the test administrator will read a passage to the participant and the child will say whether or not they recognize a series of phrases. This should take about 20 min to complete. Participants are read a passage and presented with a series of sentences. After listening to the text, they will be informed that some of the sentences they will hear are part of the text, whereas other sentences are new. They will be asked to circle "yes" on their answer sheet when they recognize the sentence as being taken directly from the text, and "no" when they think the sentence was not taken from the text and has not been heard before. It will be emphasized that participants must recognize as old only those sentences that included exactly the same words as the sentences encountered in the text. Participants will also be told that for every "yes" answer they would have to select the option "Remember" if they have a clear memory of their encounter with the sentence in mind, and they can further remember some qualitative and contextual information related to the memory itself, or select the option "Familiar" if they have the feeling that the sentence is part of the text story but they cannot recollect any qualitative detail about the encoding of the sentence.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
6-11y/o anesthetized at 0-2y/o for >2hrs
6-11yr olds anesthetized for more than120 minutes before the age of 2.
6-11y/o anesthetized @ 0-2y/o for <30min
6-11 year olds anesthetized for < 30min before the age of 2.
6-11y/o anesthetized at 4-7y/o for >2hrs
6-11 year olds anesthetized for more than 120 min between the ages of 4-7.
6-11 y/o healthy control
6-11 year olds that have never received general anesthesia.
- Examine memory in 6-11 year old children [ Time Frame: 2-3 hours/subject ]Assess recognition memory using DPSD model in 6-11 year old children
- Additional Neuropsychological evaluations [ Time Frame: 2-3 hours/subject ]WASI-2, CBCL, listening/reading comprehension (in 8-11 year olds), digit span
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): NCT02005185
|United States, California|
|University of California, Davis Center for Mind and Brain|
|Davis, California, United States, 95618|
|UCSF Benioff Children's Hospital Oakland|
|Oakland, California, United States, 94609|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Jeffrey Sall, M.D., PhD||Anesthesiologist, Professor, Researcher|