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Cortisol Response to Moderate and Deep Sedation in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265966
First Posted: December 23, 2010
Last Update Posted: March 11, 2013
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.
Information provided by (Responsible Party):
Jordan Pinsker, Tripler Army Medical Center
  Purpose

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
Adrenal Insufficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of the Normal Cortisol Response to Moderate and Deep Sedation in Adrenally Sufficient Children

Resource links provided by NLM:


Further study details as provided by Jordan Pinsker, Tripler Army Medical Center:

Primary Outcome Measures:
  • 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
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.

Enrollment: 149
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate Sedation
Children undergoing moderate sedation for procedures.
Deep Sedation
Children undergoing deep sedation for procedures.

  Eligibility

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Child presenting for routine sedation to the TAMC Pediatric Sedation Center.
  • Age 3 months to 18 years of age.
  • If female age 12 or greater OR menstruating, must not be pregnant.

Exclusion Criteria:

  • Must not have the diagnosis of adrenal insufficiency or any concerns for possible adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months.
  • Current treatment with oral steroids or has been on oral steroids in the last 3 months.
  • The use of regular inhaled corticosteroids for asthma controller treatment or intranasal steroids for allergic rhinitis is specifically NOT an exclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Hawaii
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
Sponsors and Collaborators
Tripler Army Medical Center
Investigators
Principal Investigator: Angela Hsu, MD Tripler Army Medical Center
  More Information

Publications:
Responsible Party: Jordan Pinsker, Cheif, Pediatric Endocrinology, Tripler Army Medical Center
ClinicalTrials.gov Identifier: NCT01265966     History of Changes
Other Study ID Numbers: TAMC 32H10
First Submitted: December 22, 2010
First Posted: December 23, 2010
Results First Submitted: December 8, 2012
Results First Posted: March 11, 2013
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Jordan Pinsker, Tripler Army Medical Center:
Moderate Sedation
Sedation, Deep

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Anti-Inflammatory Agents