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Functional Magnetic Resonance Imaging (fMRI) Findings in Children With Early Exposure to General Anesthesia

NCT ID: NCT01229514

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Exposed to Anesthesia

Keywords

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Children before the age of 2 years

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposure to anesthesia

fMRI

Intervention Type OTHER

fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus

Normal controls

fMRI

Intervention Type OTHER

fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus

Interventions

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fMRI

fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thomas Taghon

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Taghon, DO

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12574416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17312200 (View on PubMed)

Other Identifiers

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IRB07-00456

Identifier Type: -

Identifier Source: org_study_id