NCT02013986

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

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Du yi · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Hydronephrosis
• Congenital Choledochal Cyst
• Fracture

Interventions

Type	Name	Description
DRUG	etomidate	0.3mg/kg IV only once during induction of general anesthesia
DRUG	midazolam	midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
DRUG	propofol	2mg/kg IV only once during induction of general anesthesia

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2013-12-17
• Last updated: 2013-12-17

Locations

1 site across 1 country: China