Cortisol Response to Moderate and Deep Sedation in Children

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265966
• Other study ID #: TAMC 32H10
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: March 8, 2013
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: Tripler Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adrenal Insufficiency

Locations

Country	Name	City	State
United States	Tripler Army Medical Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Tripler Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hsu AA, von Elten K, Chan D, Flynn T, Walker K, Barnhill J, Naun C, Pedersen AM, Ponaman M, Fredericks GJ, Crudo DF, Pinsker JE. Characterization of the cortisol stress response to sedation and anesthesia in children. J Clin Endocrinol Metab. 2012 Oct;97( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Peak Salivary Cortisol Level	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.	Baseline, then every 30 minutes, and at end of procedure	No