Cortisol Response to Moderate and Deep Sedation in Children
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Observational

Summary: 
      Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or
      if cortisol levels rise under only the most invasive of procedures, regardless of the type of
      anesthetic agent used. Animal data shows significant alterations in steroid intermediates
      under anesthesia regardless of the procedure performed. Prior studies in children show
      general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the
      effects of moderate and deep sedation on cortisol levels during different types of procedures
      are unknown. General medical practice varies considerably among providers; some provide
      stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive
      and invasive procedures for patients with known adrenal insufficiency, but the doses given
      vary considerably. Others provide stress dosing only for the most invasive procedures in this
      population of patients. Currently there is no published normative data on changes in cortisol
      levels under moderate and deep sedation in adrenally sufficient children, so the normal
      response we are trying to mimic is unknown.

      We propose to measure salivary cortisol levels prospectively in adrenally sufficient children
      undergoing moderate and deep sedation to determine the normal cortisol response to the stress
      of sedation for both invasive and non-invasive procedures.

      Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary
      cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI,
      echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy)
      to determine what the normal cortisol response is to the stress of sedation during these
      procedures using various anesthetic agents.

      The primary outcome variable will be to determine peak salivary cortisol measurements during
      non-invasive and invasive procedures under different levels of sedation using various
      anesthetic agents, and correlate these with known norms in children to determine if the
      patient's hypothalamic-pituitary-adrenal axis is under stress.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female military health care beneficiaries ages 3 months to 18 years of age
        presenting to the Tripler Army Medical Center pediatric sedation uni twho do not have any
        diagnosis consistent with or concerning for adrenal insufficiency, to include recent
        tapering of exogenous steroids in the last 6 months.
      
Biospecimen description: 
      This is an observational study measuring salivary cortisol levels. No interventions will done
      based on these measurements during the study. Specimens will be disposed off at the end of
      the study.
    
Keywords: Moderate Sedation; Sedation, Deep