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

Sponsor

Du yi (Other)

Overall Status

Unknown status

CT.gov ID

NCT02013986

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Hydronephrosis Congenital Choledochal Cyst Fracture	Drug: etomidate Drug: midazolam Drug: propofol	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 1 Study of Circadian Rhythm of Salivary Cortisol in Health Children ;Phase 2 Study of Circadian Rhythm of Salivary Cortisol of Children Undergoing Surgery Using Etomidate or Not Using Etomidate.

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: etomidate & 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.	Drug: etomidate 0.3mg/kg IV only once during induction of general anesthesia Other Names: Fuerli Drug: midazolam midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia Other Names: Liyuexi
Active Comparator: midazolam & 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.	Drug: midazolam midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia Other Names: Liyuexi Drug: propofol 2mg/kg IV only once during induction of general anesthesia Other Names: Diprivan

Arm

Intervention/Treatment

Experimental: etomidate & 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.

Drug: etomidate

0.3mg/kg IV only once during induction of general anesthesia

Other Names:

Fuerli

Drug: midazolam

midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia

Other Names:

Liyuexi

Active Comparator: midazolam & 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.

Drug: midazolam

midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia

Other Names:

Liyuexi

Drug: propofol

2mg/kg IV only once during induction of general anesthesia

Other Names:

Diprivan

Outcome Measures

Primary Outcome Measures

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

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.