Adrenal Insufficiency
Conditions
Keywords
Moderate Sedation, Sedation, Deep
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.
Interventions
None listed
Sponsors
Tripler Army Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Peak Salivary Cortisol Level | 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. |
Countries
United States
Participant flow
Recruitment details
All patients were recruited over a 7 month period from the Tripler Army Medical Center Pediatric Sedation Center.
Pre-assignment details
149 patients were recruited. 117 had samples adequate for analysis. 7 patients were on inhaled and/or intranasal steroids, and were analyzed separately. Therefore 110 were included in the main analysis.
Participants by arm
| Arm | Count |
|---|---|
| Moderate Sedation Children undergoing moderate sedation for procedures. | 47 |
| Deep Sedation Children undergoing deep sedation for procedures. | 41 |
| General Anesthesia Children undergoing general anesthesia for procedures. | 29 |
| Total | 117 |
Baseline characteristics
| Characteristic | Moderate Sedation | Deep Sedation | General Anesthesia | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 41 Participants | 29 Participants | 117 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 16 Participants | 16 Participants | 59 Participants |
| Sex: Female, Male Male | 20 Participants | 25 Participants | 13 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 39 | 0 / 27 |
| serious Total, serious adverse events | 0 / 44 | 0 / 39 | 0 / 27 |
Outcome results
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.
Time frame: Baseline, then every 30 minutes, and at end of procedure
Population: All patients with adequate samples for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Sedation | Change From Baseline to Peak Salivary Cortisol Level | 2.9 Number (ratio of peak to baseline) | Standard Error 0.2 |
| Deep Sedation | Change From Baseline to Peak Salivary Cortisol Level | 4.3 Number (ratio of peak to baseline) | Standard Error 0.8 |
| General Anesthesia | Change From Baseline to Peak Salivary Cortisol Level | 3.3 Number (ratio of peak to baseline) | Standard Error 1 |