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

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ClinicalTrials.gov Identifier: NCT02013986
Recruitment Status : Unknown
Verified December 2013 by Du yi, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Du yi, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014


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 Name: Fuerli

Drug: midazolam
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
Other Name: 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 Name: Liyuexi

Drug: propofol
2mg/kg IV only once during induction of general anesthesia
Other Name: Diprivan




Primary Outcome Measures :
  1. Change from baseline in salivary cortisol at the operative day [ Time Frame: 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

  2. Change from baseline in salivary cortisol at the first day after surgery [ Time Frame: 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 :
  1. Numbers of Acquired Infection Events [ Time Frame: up to 10 days after surgery ]
    Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.

  2. Numbers of using inotropic drugs [ Time Frame: within 3 days ]
    Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.

  3. Days of stay in intensive care unit (ICU) after surgery [ Time Frame: up to 10 days after surgery ]
    Days of stay in ICU after surgery.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013986


Contacts
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Contact: Chen yijun 86-21-13764206966

Locations
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China, Shanghai
department of anesthesia of Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: Wang Yinwei    86-21-13918690528      
Principal Investigator: Du yi         
Sponsors and Collaborators
Du yi
Investigators
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Study Director: Wng Y Wei, professor Shanghai Jiao Tong University School of Medicine

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Responsible Party: Du yi, attending of anesthesiology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02013986     History of Changes
Other Study ID Numbers: X01PA131001
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Du yi, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
salivary cortisol
circadian rhythm
children
etomidate
Additional relevant MeSH terms:
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Choledochal Cyst
Hydronephrosis
Kidney Diseases
Urologic Diseases
Cysts
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Midazolam
Propofol
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents