Clinical trial NCT01359215: Childhood Anesthesia and Cognitive Function
Official title: Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Deficits
Cognitive Ability, General
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2011-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who received an anesthetic early in life

Brief summary: The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction

Detailed description: Contrary to a longstanding belief, anesthesia has lasting effects on the neonatal brain. In rats anesthesia causes death of brain cells, ill-timed conversion of stem cells to nerve cells and a certain kind of brain defect up to 8 months later. This brain defect is called a hippocampal deficit because it resembles the type of defect that people have when a structure in the brain called the hippocampus has been injured, removed or is no longer functioning. However, to date it is unknown if anesthesia given to human infants causes a lasting hippocampal deficit, which might manifest itself as memory problems and academic failure despite normal intelligence. The investigators will test the hypothesis that anesthesia for more than 2h given to children of less than 2 years of age without coexisting diseases of the brain or the heart causes long-term impairment of hippocampal function. Using state of the art hippocampal and general brain function testing the investigators will compare hippocampal dependent and hippocampal independent memory as well as general cognitive function and emotional state in 10 year-old children that underwent at least a 2h anesthetic at less than 2 years with that of a matched control group that did not undergo an anesthetic.

Eligibility criteria: Inclusion Criteria:

* Anesthesia at less than 2 years of age
* Anesthetic time greater than 2 hours
* ASA I or II
* Induction with Propofol or Sevoflurane +/- N2O
* Maintenance with a volatile agent (sevoflurane, isoflurane, desflurane) +/- N2O

Exclusion Criteria:

* Neurosurgery
* Known genetic syndrome
* Any other anesthetic agents (ketamine, meperidine, barbiturates, etomidate, methoxyflurane, methadone, lorazepam)
* Low birthweight (\<25%ile)
* Gestational age , 36 weeks
* color blindness
* h/o CNS disease
* cancer
* head trauma
* congenital heart disease
* ASA III or IV
* intra-operative hypotension (\<30% baseline for \> 5 min)
* Bradycardia (\<30% baseline for \> 5 min)
* Hypoxemia (Blood Oxygen Saturation \<93% for \> 5 min)
* Hypercarbia (pCO2 \> 60 mm Hg \> 5 min)
* Dysthermia (deviation from 36.5 deg C by \> 1.5 deg C at any time)
* Puberty

Primary outcomes:
measure: Recollection
timeFrame: 6-12 years of age
Secondary outcomes:
measure: Familiarity, Child behavioral checklist
timeFrame: 6-12 years of age
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of Califoria, Davis
state: California
city: San Francisco
country: United States
facility: Univeristy of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Greg Stratmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: