Congenital Choledochal Cyst, Congenital Hydronephrosis, Fracture
Conditions
Keywords
salivary cortisol, circadian rhythm, children, etomidate
Brief summary
Etomidate is an unique drug used for induction of general anesthesia and sedation. Adrenal cortical inhibition by etomidate has received much attention. However wether the circadian rhythm and pulse secretion pattern of cortisol in children are the same as that in adults is not known. Moreover, the effect of etomidate on circadian rhythm changes and clinical outcomes has never been carefully studied in children undergoing surgery. Our hypothesis is that etomidate can relieve the changes of circadian rhythm of salivary cortisol in children for 24-48 hours，and this does not make clinical outcomes worse postoperatively.
Detailed description
* Sample size assessment: Using formula to calculate the total number is 30. * Statistical analysis: ANOVA * Reporting for adverse events: During the period of study, if there is any severe adverse event happening, such as severe infection, severe low cortisol concentration threatening the patient's life we will stop the trial.
Interventions
DRUGetomidate
0.3mg/kg IV only once during induction of general anesthesia
DRUGmidazolam
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
DRUGpropofol
2mg/kg IV only once during induction of general anesthesia
Sponsors
Du yi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 3-12 years old who are plan to undergo surgery
Exclusion criteria
* endocrine disease, blood infusion, having fever, ulcer or bleeding in the oral cavity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in salivary cortisol at the operative day | baseline(8am), 8pm | At the time of 8am(baseline) and at the time of 8pm in the operative day , get salivary samples to calculate the change of salivary cortisol |
| Change from baseline in salivary cortisol at the first day after surgery | baseline(8am), 8pm | At the time of 8am(baseline) and at the time of 8pm in the first day after surgery , get salivary samples to calculate the change of salivary cortisol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Acquired Infection Events | up to 10 days after surgery | Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery. |
| Numbers of using inotropic drugs | within 3 days | Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine. |
| Days of stay in intensive care unit (ICU) after surgery | up to 10 days after surgery | Days of stay in ICU after surgery. |
Countries
China
Contacts
Primary ContactChen yijun
Outcome results
None listed