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

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.

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change from baseline in salivary cortisol at the operative day

Secondary Outcome

 Numbers of Acquired Infection Events

Condition

Congenital Hydronephrosis

Intervention

etomidate

Study Arms / Comparison Groups

 etomidate & midazolam
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

September 2013

Completion Date

August 2014

Primary Completion Date

June 2014

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
      

Gender

All

Ages

3 Years - 12 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Wng Y Wei, professor, 86-21-13764206966, 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02013986

Organization ID

X01PA131001


Responsible Party

Sponsor-Investigator

Study Sponsor

Du yi


Study Sponsor

Wng Y Wei, professor, Study Director, Shanghai Jiao Tong University School of Medicine


Verification Date

December 2013