• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Pediatric Anesthesia Research

Description: The use of imaging approaches to evaluate the neurotoxicity associated with exposure to the pediatric anesthetics sevoflurane and propofol - This study is a collaborative effort with the Center for Drug Evaluation and Research (CDER). MicroPET imaging allows for the non-invasive, in vivo quantification of lesion- or treatment-induced neurochemical and pathological changes in small animal models. Coupled with computed tomography (CT), neuronal damage can be localized and repeatedly monitored over time. In addition, a variety of tracers may be used in the same animal to investigate multiple disease or toxic mechanisms. Both in vitro and in vivo studies will be conducted to test the hypothesis that neural stem cells are adversely affected by general anesthetics such that they inhibit proliferation and cause cell death.

Definition: Oxidative stress is caused by an imbalance in cells between reactive oxygen and their ability to detoxify reactive oxygen. This ability is related to aging and to several diseases. Mitochondrial toxicity occurs when the mitochondria of the body's cells become damaged or decline significantly in number. These conditions are studied here in relationship to neurotoxicity and neurodegeneration, both of which can cause loss of cognitive function.

Accomplishment: NCTR scientists have defined pathways behind brain damage associated with exposure to general anesthetics such as Propofol. Scientists at the Center specifically studied exposures occurring during the early to late stages of infant development and have also discovered that the compound acetyl-L-carnitine does act as a neuroprotective agent. This research increases our knowledge of how the body is affected by various general anesthetics and how these effects can be lessened in the future.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Submit protocol to evaluate (by molecular imaging approach) the proliferation rate and potential neurotoxicity of neural stem cells associated with anesthetic exposure

1/10/2013

Completed 1/10/2013

b. Develop new PET tracer for neural stem cell proliferation

3/1/2013

Completed 3/1/2013

c. Obtain raw data from sevoflurane studies

6/1/2013

Completed 6/1/2013

d. Submit abstract for sevoflurane

7/1/2013

Completed 7/1/2013

e. Collect initial propofol raw data and submit abstract

FY14 Q2

Completed 12/1/2013

f. Submit manuscript for sevoflurane

5/31/2014

Completed 4/30/2014

g. Develop second propofol abstract

FY14 Q3

Completed 6/1/2014

h. Prepare draft propofol manuscript

TBD

Completed 6/15/2014

i. Submit propofol manscript for publication

TBD

Completed 6/30/2014

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

in vivo

Within a living organism

in vitro

In an artificial environment outside the living organism

proliferation

Growth or multiplication by rapidly producing new tissue, parts, cells, or offspring.

PET tracer

Positron emission tomography (PET) - uses a radioactive substance called a tracer to look for disease in the body

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.