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

NCT ID: NCT02013986

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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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

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* 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

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Congenital Hydronephrosis Congenital Choledochal Cyst Fracture

Keywords

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etomidate salivary cortisol circadian rhythm children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

etomidate

Intervention Type DRUG

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

midazolam

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

propofol

Intervention Type DRUG

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

Interventions

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etomidate

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

Intervention Type DRUG

midazolam

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

Intervention Type DRUG

propofol

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

Intervention Type DRUG

Other Intervention Names

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Fuerli Liyuexi Diprivan

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Du yi

OTHER

Sponsor Role lead

Responsible Party

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Du yi

attending of anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wng Y Wei, professor

Role: STUDY_DIRECTOR

Shanghai Jiao Tong University School of Medicine

Locations

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department of anesthesia of Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen yijun

Role: CONTACT

Phone: 86-21-13764206966

Facility Contacts

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Wang Yinwei

Role: primary

Other Identifiers

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X01PA131001

Identifier Type: -

Identifier Source: org_study_id