Cortisol Response to Moderate and Deep Sedation in Children

NCT01265966 | Completed Results DMC

• 1 other identifier: TAMC 32H10
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Moderate Sedation; Sedation, Deep

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Moderate Sedation

Children undergoing moderate sedation for procedures.

Deep Sedation

Children undergoing deep sedation for procedures.

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tripler Army Medical Center: lead

Study Sites (1)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Related 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(10):E1830-5. doi: 10.1210/jc.2012-1499. Epub 2012 Aug 1.

  PMID: 22855336 RESULT

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.

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Limitations and Caveats

There is concern that the presence of a cortisol response is merely a biochemical phenomena and not of clinical importance for minor surgeries/mild stress.

Results Point of Contact

• Title: Dr. Jordan Pinsker
• Organization: Tripler Army Medical Center

jordan.pinsker@us.army.mil

808-433-6338

Study Officials

• Angela Hsu, MD

  Tripler Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cheif, Pediatric Endocrinology

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 11, 2013
• Results First Posted: March 11, 2013

Record last verified: 2013-03

Locations

US (1)