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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etomidate & midazolam | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etomidate | Drug | 0.3mg/kg IV only once during induction of general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in salivary cortisol at the operative day | 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 | baseline(8am), 8pm |
| Change from baseline in salivary cortisol at the first day after surgery | 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 | baseline(8am), 8pm |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Acquired Infection Events | Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery. | up to 10 days after surgery |
| Numbers of using inotropic drugs | Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen yijun | Contact | 86-21-13764206966 |
| Name | Affiliation | Role |
|---|---|---|
| Wng Y Wei, professor | Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of anesthesia of Xinhua Hospital | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 19, 2015 | |
| Reset | Jun 3, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 19, 2015 | Jun 3, 2015 |
| ID | Term |
|---|---|
| D015529 | Choledochal Cyst |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| midazolam | Drug | midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia |
|
|
| propofol | Drug | 2mg/kg IV only once during induction of general anesthesia |
|
|
| within 3 days |
| Days of stay in intensive care unit (ICU) after surgery | Days of stay in ICU after surgery. | up to 10 days after surgery |
| D004066 |
| Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014947 | Wounds and Injuries |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |