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

Phase 4

• Conditions: Congenital Hydronephrosis; Congenital Choledochal Cyst; Fracture
• Interventions: Drug: etomidate; Drug: midazolam; Drug: propofol

• Registration Number: NCT02013986
• Lead Sponsor: Du yi

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-07
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17
• Primary Completion: 2014-06
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
etomidate & midazolam	midazolam	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.
etomidate & midazolam	etomidate	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.
midazolam & propofol	propofol	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.
midazolam & propofol	midazolam	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

department of anesthesia of Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China