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

Fracture Clinical Trial

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.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02013986
• Other study ID #: X01PA131001
• Status: Unknown status
• Phase: Phase 4
• First received: November 7, 2013
• Last updated: December 11, 2013
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2013
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Chen yijun
• Phone: 86-21-13764206966
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Choledochal Cyst
• Congenital Choledochal Cyst
• Congenital Hydronephrosis
• Fracture
• Hydronephrosis

Intervention

Drug:
• etomidate
0.3mg/kg IV only once during induction of general anesthesia
• midazolam
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
• propofol
2mg/kg IV only once during induction of general anesthesia

Locations

Country	Name	City	State
China	department of anesthesia of Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Du yi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline(8am), 8pm
Primary	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	baseline(8am), 8pm
Secondary	Numbers of Acquired Infection Events	Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.	up to 10 days after surgery
Secondary	Numbers of using inotropic drugs	Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.	within 3 days
Secondary	Days of stay in intensive care unit (ICU) after surgery	Days of stay in ICU after surgery.	up to 10 days after surgery