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

Du yi

Status and phase: Unknown; Phase 4

Conditions: Congenital Choledochal Cyst; Fracture; Congenital Hydronephrosis

Treatments: Drug: propofol; Drug: midazolam; Drug: etomidate

Study type: Interventional

Funder types: Other

Identifiers

NCT02013986

X01PA131001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

etomidate & midazolam

Experimental group

Description:

a bolus of midazolam(Jiangsu Enhua Pharmaceutical Ltd.) 0.1mg/kg then a bolus of etomidate(Etomidate Fat Emulsion Injection, Jiangsu Enhua Pharmaceutical Ltd.)0.3 mg/kg and intravenously, during induction period, the other steps as usual.

Treatment:

Drug: etomidate

Drug: midazolam

midazolam & propofol

Active Comparator group

Description:

During induction period,use a bolus of midazolam injection 0.1mg/kg(Jiangsu Enhua Pharmaceutical Ltd.) and then a bolus of propofol injection 2mg/kg(Astrazeneca PLC.)intravenously, the other steps are as usual.

Treatment:

Drug: midazolam

Drug: propofol