A Phase 4 interventional study of etomidate and midazolam in Congenital Hydronephrosis, Congenital Choledochal Cyst and Fracture, sponsored by Du yi. Status unknown at 1 site in China. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-17.
Sponsored by Du yi · Phase 4, Interventional, and Treatment
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.
22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.
Browse Choledochal Cyst studies →This is the only study on the registry with Du yi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Drug: 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.
Drug: midazolam · Drug: propofol
0.3mg/kg IV only once during induction of general anesthesia
Also known as: Fuerli
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
Also known as: Liyuexi
2mg/kg IV only once during induction of general anesthesia
Also known as: Diprivan
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
Time frame: 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
Time frame: baseline(8am), 8pm
Numbers of Acquired Infection Events
Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.
Time frame: up to 10 days after surgery
Numbers of using inotropic drugs
Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.
Time frame: within 3 days
Days of stay in intensive care unit (ICU) after surgery
Days of stay in ICU after surgery.
Time frame: up to 10 days after surgery
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Etomidate