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

NCT01229514 | Completed

• 1 other identifier: IRB07-00456
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Exposed to Anesthesia

Keywords

Children; before; the age of 2 years

Outcome Measures

Primary Outcomes (1)

• Use of fMRI as a tool

  To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development

  one time 10 to 17 yrs. post-anesthesia

Secondary Outcomes (1)

• Brain activation patterns

  one time 10 to 17 yrs. post-anesthesia

Study Arms (2)

Exposure to anesthesia

Other: fMRI

Normal controls

Other: fMRI

Interventions

fMRI OTHER

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

Exposure to anesthesia; Normal controls

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children from Nationwide Children's Hospital

You may qualify if:

• 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.
• The cognitive ability to complete fMRI imaging.
• Consent of the subject's guardians and assent of the subject.
• Right hand dominance.
• English language speaker.

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• 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.

  PMID: 12574416 BACKGROUND

• 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.

  PMID: 17312200 BACKGROUND

Study Officials

• Thomas Taghon, DO

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 2, 2012

Record last verified: 2012-06

Locations

US (1)