Congenital HydronephrosisPhase 4NCT02013986
Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children
A Phase 4 study testing etomidate, midazolam and propofol in people with Congenital Hydronephrosis and Congenital Choledochal Cyst, run by Du yi at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hydronephrosis, Congenital Choledochal Cyst, Fracture
- What is being tested?
- etomidate, midazolam and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-12 years old who are plan to undergo surgery
Who cannot join
- endocrine disease, blood infusion, having fever, ulcer or bleeding in the oral cavity
Trial locations and contacts
1 site in 1 country.
Chen yijun contact
China1 site, 1 recruiting
- Recruiting
department of anesthesia of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Wang Yinwei, 86-21-13918690528
Du yi
About this study
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.
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.
Read the 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.
- Keywords
- salivary cortisol, circadian rhythm, children, etomidate
- Medical subject headings
- Choledochal Cyst, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etomidateDrug
Also called Fuerli
0.3mg/kg IV only once during induction of general anesthesia
midazolamDrug
Also called Liyuexi
midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
propofolDrug
Also called Diprivan
2mg/kg IV only once during induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: midazolam; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline(8am), 8pm
Secondary outcomes (3)
Numbers of Acquired Infection Events
Acquired infection using extra antibiotics(not prophylactic antibiotics) after surgery.
Measured: up to 10 days after surgery
Numbers of using inotropic drugs
Inotropic drugs include norepinephrine, adrenaline, phenylephrine and dopamine.
Measured: within 3 days
Days of stay in intensive care unit (ICU) after surgery
Days of stay in ICU after surgery.
Measured: up to 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HydronephrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du yi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Du yi, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wng Y Wei, professor, Study director, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013986
- Sponsor's protocol ID
- X01PA131001
- Status last verified
- Dec 2013
- First submitted
- 7 Nov 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02013986
- Acronym / sponsor ID
- X01PA131001
- Keywords
- salivary cortisol, circadian rhythm, children, etomidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Du yiUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etomidate & midazolam | Experimental | Drug: etomidate, Drug: midazolama 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. |
| midazolam & propofol | Active comparator | Drug: midazolam, Drug: propofolDuring 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3-12 years old who are plan to undergo surgery
Key exclusion criteria (1 listed)
- endocrine disease, blood infusion, having fever, ulcer or bleeding in the oral cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etomidateAlso: Fuerli0.3mg/kg IV only once during induction of general anesthesia | Drug | etomidate & midazolam |
| midazolamAlso: Liyueximidazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia | Drug | etomidate & midazolam, midazolam & propofol |
| propofolAlso: Diprivan2mg/kg IV only once during induction of general anesthesia | Drug | midazolam & propofol |
Primary outcome
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
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
3 secondary outcomes
Numbers of Acquired Infection Events
Time frame: up to 10 days after surgery
Numbers of using inotropic drugs
Time frame: within 3 days
Days of stay in intensive care unit (ICU) after surgery
Time frame: up to 10 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen yijun contact
Wng Y Wei, professor study director
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etomidate, midazolam and propofol in people with Congenital Hydronephrosis and Congenital Choledochal Cyst, run by Du yi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen yijun (86-21-13764206966), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in salivary cortisol at the operative day (time frame: baseline(8am), 8pm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.