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

NCT02013986 | Unknown Phase 4 DMC

• 1 other identifier: X01PA131001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Hydronephrosis; Congenital Choledochal Cyst; Fracture

Keywords

salivary cortisol; circadian rhythm; children; etomidate

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Numbers of Acquired Infection Events

  up to 10 days after surgery

• Numbers of using inotropic drugs

  within 3 days

• Days of stay in intensive care unit (ICU) after surgery

  up to 10 days after surgery

Study Arms (2)

etomidate & midazolam

EXPERIMENTAL

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; Drug: midazolam

midazolam & propofol

ACTIVE COMPARATOR

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; Drug: propofol

Interventions

etomidate DRUG

0.3mg/kg IV only once during induction of general anesthesia

Also known as: Fuerli

etomidate & midazolam

midazolam DRUG

midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia

Also known as: Liyuexi

etomidate & midazolam; midazolam & propofol

propofol DRUG

2mg/kg IV only once during induction of general anesthesia

Also known as: Diprivan

midazolam & propofol

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old who are plan to undergo surgery

You may not qualify if:

• endocrine disease, blood infusion, having fever, ulcer or bleeding in the oral cavity

Sponsors & Collaborators

• Du yi: lead

Study Sites (1)

department of anesthesia of Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Choledochal Cyst; Fractures, Bone

Interventions

Etomidate; Midazolam; Propofol

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Wng Y Wei, professor

  Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Chen yijun

CONTACT

86-21-13764206966

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending of anesthesiology

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: December 17, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

CN (1)