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

Completed

• Conditions: Exposed to Anesthesia
• Interventions: Other: fMRI

• Registration Number: NCT01229514
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure to anesthesia	fMRI	-
Normal controls	fMRI	-

Primary Outcome Measures

Name	Time	Method
Use of fMRI as a tool	one time 10 to 17 yrs. post-anesthesia	To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development

Secondary Outcome Measures

Name	Time	Method
Brain activation patterns	one time 10 to 17 yrs. post-anesthesia	To compare brain activation patterns in children with and without a history of early exposure to general anesthetic medications while peforming a specific task (go/no-go).

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States