Clinical trial NCT01229514: Functional Magnetic Resonance Imaging (fMRI) Findings in Children With Early Exposure to General Anesthesia
Official title: A Comparison of Functional Magnetic Resonance Imaging (fMRI) Findings in Children With and Without a History of Early Exposure to General Anesthetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposed to Anesthesia
Keywords: Children
before
the age of 2 years
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from Nationwide Children's Hospital

Brief summary: General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI (fMRI) is a technique developed for mapping brain activation and has been utilized to examine how the brains of children with a history of early exposure to ethanol function differently from children without such a history. This study will utilize fMRI to look for specific changes in brain activation patterns in children with a history of early exposure to general anesthesia, as compared to children without such exposure.


Eligibility criteria: Inclusion Criteria:

1. Children ages 10-17 years with an history of exposure to general anesthesia for at least one hour in duration during the ages of 0-24 months of age.
2. The cognitive ability to complete fMRI imaging.
3. Consent of the subject's guardians and assent of the subject.
4. Right hand dominance.
5. English language speaker.

Exclusion Criteria:

1. Subjects with known possibility or knowledge of pregnancy.
2. Documentation of hemodynamic or respiratory instability documented on the anesthetic record
3. Subjects with the inability to complete MRI imaging without sedation.
4. History of prenatal ethanol exposure.
5. History of exposure to antiepileptic medication.
6. History of Attention Deficit Disorder (ADD), or Attention Deficit Hyperactivity Disorder (ADHD)
7. History of traumatic brain injury
8. History of psychiatric disease or exposure to psychoactive medications.
9. History of substance abuse.

Primary outcomes:
measure: Use of fMRI as a tool
timeFrame: one time 10 to 17 yrs. post-anesthesia
Secondary outcomes:
measure: Brain activation patterns
timeFrame: one time 10 to 17 yrs. post-anesthesia
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Thomas Taghon, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.
citation: Mellon RD, Simone AF, Rappaport BA. Use of anesthetic agents in neonates and young children. Anesth Analg. 2007 Mar;104(3):509-20. doi: 10.1213/01.ane.0000255729.96438.b0.