NCT01265966

Cortisol Response to Moderate and Deep Sedation in Children

Characterization of the Normal Cortisol Response to Moderate and Deep Sedation in Adrenally Sufficient Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: Tripler Army Medical Center · Federal
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenal Insufficiency

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-12-23
• Last updated: 2013-03-11
• Results posted: 2013-03-11

Locations

1 site across 1 country: United States