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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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 Summary:

  • 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.

Sponsor: Du yi

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Numbers of Acquired Infection Events [ Time Frame: up to 10 days after surgery ]
    Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.
  • Numbers of using inotropic drugs [ Time Frame: within 3 days ]
    Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.
  • 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.


Original Secondary Outcome: Same as current

Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: November 7, 2013
Date Started: September 2013
Date Completion: August 2014
Last Updated: December 11, 2013
Last Verified: December 2013