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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
Sponsor:
Collaborators:
University of California, Davis
UCSF Benioff Children’s Hospital Oakland
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Anesthesia for more than 120 minutes given to children less than 2 years of age without coexisting diseases of the central nervous system or the heart cause long-term impairment of recognition memory.

Condition or disease
Procedures Requiring Anesthesia

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Additional Neuropsychological evaluations [ Time Frame: 2-3 hours/subject ]
    WASI-2, CBCL, listening/reading comprehension (in 8-11 year olds), digit span



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children currently 6-11 years old who have been anesthetized between ages 0-2 or between ages 4-7 and a matched group of children that did not undergo anesthesia.
Criteria

Inclusion Criteria:

  • General anesthesia for more than 120 minutes between birth and 2 years of age or between ages 4-7
  • General anesthesia for less than 30 minutes before the age of 2.
  • Use of volatile anesthetic (sevoflurane, isoflurane, halothane or desflurane) with or without nitrous oxide for maintenance of anesthesia.
  • Use of fentanyl or morphine as opioids and midazolam as premedication is acceptable. Propofol used for induction only is acceptable.
  • Control subjects must never have been exposed to anesthesia or sedation for any procedure.
  • English and Spanish speaking subjects

Exclusion Criteria:

  • Use of any other agents such as ketamine, meperidine, barbiturates, etomidate, methoxyflurane, chloral hydrate, methadone or lorazepam.
  • Low birth weight (<25th percentile)
  • premature birth at <36 weeks
  • color blindness
  • history of brain disease including head trauma
  • presence of congenital heart disease
  • any other metabolic disease (i.e. diabetes),cancer, or known genetic syndrome.
  • significant low blood pressure during their surgery (<30% of baseline for >5min)
  • abnormal temperature (deviation from 36.5 degrees C by >1.5 degree C at any point)
  • slow heart rate
  • low blood oxygen saturation (<93% for >5min.)
  • high arterial carbon dioxide levels (>60mm Hg for >5min.)
  • control subjects are excluded for any exposure to anesthesia or sedation

Information from the National Library of Medicine

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


Locations
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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
UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
UCSF Benioff Children’s Hospital Oakland
Investigators
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Principal Investigator: Jeffrey Sall, M.D., PhD Anesthesiologist, Professor, Researcher

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02005185     History of Changes
Other Study ID Numbers: Anes255HippocampalDysfcn
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs