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NCT01265966 · ClinicalTrials.gov registry record
Cortisol Response to Moderate and Deep Sedation in Children
A clinical trial of Adrenal Insufficiency, sponsored by Tripler Army Medical Center.
- Completed
- Registry status
- 149
- Enrollment target
- 1
- Study location
NCT01265966 is a study of Adrenal Insufficiency that has completed, run by Tripler Army Medical Center. The registered enrollment target is 149 participants, below the 3,037-participant average among 5 other Adrenal Insufficiency trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01265966, a study of Adrenal Insufficiency, has completed, sponsored by Tripler Army Medical Center.
- COMPLETED
- Registry status
- 149 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Study Locations (1)
Hawaii
- Tripler Army Medical Center - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01265966
The ClinicalTrials.gov registry entry for NCT01265966 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,037-participant average among 5 other Adrenal Insufficiency trials with a reported enrollment target (95% lower). The listed sponsor is Tripler Army Medical Center, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adrenal Insufficiency appearing as the primary indexed condition, and to 0 interventions.
NCT01265966 reports 1 study location spanning 1 distinct geographic area - top geographies include Hawaii.
Frequently Asked Questions
What is clinical trial NCT01265966 about?
NCT01265966 is a clinical study titled "Cortisol Response to Moderate and Deep Sedation in Children". 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 regardl...
What is the current status of trial NCT01265966?
This trial is currently completed. The enrollment target is 149 participants. The study started on 2010-12. Estimated completion is 2011-07.
What conditions does trial NCT01265966 study?
This clinical trial studies the following conditions: Adrenal Insufficiency.
Who is sponsoring clinical trial NCT01265966?
This trial is sponsored by Tripler Army Medical Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01265966 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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