Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction

Study Overview
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Brief Summary
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This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician.

Conditions
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Bispectral Index, Pediatric, Etomidate, Induction

Intervention / Treatment
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* Drug: etomidate
* Drug: propofol
* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obtain informed consent; undergoing elective hypospadias repair surgery under general anesthesia; American society of anesthesiologists (ASA) class I-II; aged between 3-10 years old; BMI is 18.5-30 kg/m2; Exclusion Criteria: systolic blood pressure≥180 mmHg or<90 mmHg, diastolic blood pressure≥110 mmHg or<60 mmHg; serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections; long-term use of hormone or a history of adrenal cortex inhibition; suspected or confirmed difficult airway; suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs; neuromuscular disease; mental instability, or have a mental illness; allergic to investigational products or with other contraindication participated in other study within 30 days

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etomidate group<br>infusion of etomidate at 2 minutes before anesthesia induction | Drug: etomidate<br>* intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. infusion of etomidate at 2 minutes before anesthesia induction<br>|
| Active Comparator: propofol group<br>infusion of propofol at 2 minutes before anesthesia induction | Drug: propofol<br>* intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. infusion of propofol at 2 minutes before anesthesia induction<br>|
| Active Comparator: sevoflurane group<br>inhale sevoflurane for anesthesia induction and maintenance | Drug: sevoflurane<br>* intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. inhale sevoflurane for anesthesia induction and maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of drugs | the amount of etomidate,propofol and sevoflurane used in anesthesia induction | from the beginning of induction to Bispectral Index < 50,up to 5 minutes | 
| the drugs used time | the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction | from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute | 
| numbers of muscular fibrillation | numbers of muscular fibrillation in anesthesia induction | from the beginning of induction to Bispectral Index < 50,up to 5 minutes | 
| degree of inflammation reaction | serum levels of interleukin 6 and tumor necrosis factor α will be measured at each time point using ELISA method | baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation | 
| adrenal function | serum level of cortisol will be measured at each time point using radioimmunoassay | baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic parameters | heart rate,blood pressure,electrocardiogram and pulse oxygen saturation recorded at 4 time points including before anesthesia induction,before endotracheal intubation,after endotracheal intubation and after operation immediately | from the beginning of induction to skin closure, up to 3 hours | 
| sedation degree | Bispectral index,train-of-four stimulation and the temperature recorded at 4 time points including before anesthesia induction,before endotracheal intubation,after endotracheal intubation and after operation immediately | from the beginning of induction to skin closure, up to 3 hours |