Cortisol Response to Moderate and Deep Sedation in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children

NCT02013986

Congenital Hydronephrosis Congenital Choledochal Cyst Fracture

UNKNOWN PHASE4

The Influence of Induction Anesthetic Agents on Serum Cortisol Concentration in Morbidly Obese Patients.

NCT01930019

Obesity

COMPLETED NA

Genetic Differences in Propofol Pharmacodynamics in Children

NCT04164264

Anesthesia

ACTIVE_NOT_RECRUITING PHASE4

Memory During Anesthesia: the Role of Stress Hormones

NCT01146405

Surgical Procedure, Unspecified

UNKNOWN

Cortisol Level After Repeated Doses of Etomidate

NCT03188029

Adrenocortical Abnormality

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adrenal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Moderate Sedation

Children undergoing moderate sedation for procedures.

No interventions assigned to this group

Deep Sedation

Children undergoing deep sedation for procedures.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No