Cortisol Response to Moderate and Deep Sedation in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01265966|
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Observational Model:||Case Control|
|Official Title:||Characterization of the Normal Cortisol Response to Moderate and Deep Sedation in Adrenally Sufficient Children|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Children undergoing moderate sedation for procedures.
Children undergoing deep sedation for procedures.
- Change From Baseline to Peak Salivary Cortisol Level [ Time Frame: Baseline, then every 30 minutes, and at end of procedure ]Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265966
|United States, Hawaii|
|Tripler Army Medical Center|
|Honolulu, Hawaii, United States, 96859|
|Principal Investigator:||Angela Hsu, MD||Tripler Army Medical Center|