Back to resultsEffects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children
Primary Purpose
Congenital Hydronephrosis, Congenital Choledochal Cyst, Fracture
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
etomidate
midazolam
propofol
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Hydronephrosis focused on measuring salivary cortisol, circadian rhythm, children, etomidate
Eligibility Criteria
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
Sites / Locations
- department of anesthesia of Xinhua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
etomidate & midazolam
midazolam & propofol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Numbers of Acquired Infection Events
Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.
Numbers of using inotropic drugs
Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.
Days of stay in intensive care unit (ICU) after surgery
Days of stay in ICU after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02013986
Brief Title
Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Du yi
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hydronephrosis, Congenital Choledochal Cyst, Fracture
Keywords
salivary cortisol, circadian rhythm, children, etomidate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
etomidate & midazolam
Arm Type
Experimental
Arm Description
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.
Arm Title
midazolam & propofol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
etomidate
Other Intervention Name(s)
Fuerli
Intervention Description
0.3mg/kg IV only once during induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
midazolam
Other Intervention Name(s)
Liyuexi
Intervention Description
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
Diprivan
Intervention Description
2mg/kg IV only once during induction of general anesthesia
Primary Outcome Measure Information:
Title
Change from baseline in salivary cortisol at the operative day
Description
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
Title
Change from baseline in salivary cortisol at the first day after surgery
Description
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
Secondary Outcome Measure Information:
Title
Numbers of Acquired Infection Events
Description
Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.
Time Frame
up to 10 days after surgery
Title
Numbers of using inotropic drugs
Description
Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.
Time Frame
within 3 days
Title
Days of stay in intensive care unit (ICU) after surgery
Description
Days of stay in ICU after surgery.
Time Frame
up to 10 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen yijun
Phone
86-21-13764206966
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wng Y Wei, professor
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
department of anesthesia of Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Yinwei
Phone
86-21-13918690528
First Name & Middle Initial & Last Name & Degree
Du yi
12. IPD Sharing Statement
Learn more about this trial
Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children
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