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

December 11, 2013 updated by: Du yi

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chen yijun
  • Phone Number: 86-21-13764206966

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • department of anesthesia of Xinhua Hospital
        • Contact:
          • Wang Yinwei
          • Phone Number: 86-21-13918690528
        • Principal Investigator:
          • Du yi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: etomidate & midazolam
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
0.3mg/kg IV only once during induction of general anesthesia
Other Names:
  • Fuerli
Drug: midazolam
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
Other Names:
  • Liyuexi
Active Comparator: midazolam & propofol
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
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
Other Names:
  • Liyuexi
Drug: propofol
2mg/kg IV only once during induction of general anesthesia
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline(8am), 8pm
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
baseline(8am), 8pm

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Du yi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X01PA131001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fracture

Clinical Trials on etomidate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe