Bispectral IndexPhase 4NCT02182648
Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction
A Phase 4 study testing etomidate, propofol and sevoflurane in people with Bispectral Index and Pediatric, run by Henan Provincial People's Hospital.
Trial summary
This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Bispectral Index, Pediatric, Etomidate
- What is being tested?
- etomidate, propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2015
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- obtain informed consent;
- undergoing elective hypospadias repair surgery under general anesthesia;
- American society of anesthesiologists (ASA) class I-II;
- aged between 3-10 years old;
- BMI is 18.5-30 kg/m2;
Who cannot join
- systolic blood pressure≥180 mmHg or<90 mmHg, diastolic blood pressure≥110 mmHg or<60 mmHg;
- serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- long-term use of hormone or a history of adrenal cortex inhibition;
- suspected or confirmed difficult airway;
- suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs;
- neuromuscular disease;
Show all 9Show fewer
- mental instability, or have a mental illness;
- allergic to investigational products or with other contraindication
- participated in other study within 30 days
Trial locations and contacts
No sites are listed yet.
Enqiang Chang contact
About this study
This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician.
- Conditions
- Bispectral Index, Pediatric, Etomidate, Induction
- Being tested
- etomidate, propofol, sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etomidateDrug
- intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia.
- infusion of etomidate at 2 minutes before anesthesia induction
propofolDrug
- intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia.
- infusion of propofol at 2 minutes before anesthesia induction
sevofluraneDrug
- intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia.
- inhale sevoflurane for anesthesia induction and maintenance
| Study group | Role | What they receive |
|---|---|---|
| etomidate group | Experimental | infusion of etomidate at 2 minutes before anesthesia induction Receives: Drug: etomidate |
| propofol group | Active comparator | infusion of propofol at 2 minutes before anesthesia induction Receives: Drug: propofol |
| sevoflurane group | Active comparator | inhale sevoflurane for anesthesia induction and maintenance Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of drugs
the amount of etomidate,propofol and sevoflurane used in anesthesia induction
Measured: from the beginning of induction to Bispectral Index < 50,up to 5 minutes
the drugs used time
the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction
Measured: from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute
numbers of muscular fibrillation
numbers of muscular fibrillation in anesthesia induction
Measured: from the beginning of induction to Bispectral Index < 50,up to 5 minutes
degree of inflammation reaction
serum levels of interleukin 6 and tumor necrosis factor α will be measured at each time point using ELISA method
Measured: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation
adrenal function
serum level of cortisol will be measured at each time point using radioimmunoassay
Measured: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation
Secondary outcomes (2)
hemodynamic parameters
heart rate,blood pressure,electrocardiogram and pulse oxygen saturation recorded at 4 time points including before anesthesia induction,before endotracheal intubation,after endotracheal intubation and after operation immediately
Measured: from the beginning of induction to skin closure, up to 3 hours
sedation degree
Bispectral index,train-of-four stimulation and the temperature recorded at 4 time points including before anesthesia induction,before endotracheal intubation,after endotracheal intubation and after operation immediately
Measured: from the beginning of induction to skin closure, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bispectral IndexStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182648
- Sponsor's protocol ID
- etomidate children 20140625
- Status last verified
- Jun 2014
- First submitted
- 29 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction
- ClinicalTrials.gov ID
- NCT02182648
- Acronym / sponsor ID
- etomidate children 20140625
- Conditions
- Bispectral Index, Pediatric, Etomidate, Induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 8 Jul 2014 (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.
This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etomidate group | Experimental | Drug: etomidateinfusion of etomidate at 2 minutes before anesthesia induction |
| propofol group | Active comparator | Drug: propofolinfusion of propofol at 2 minutes before anesthesia induction |
| sevoflurane group | Active comparator | Drug: sevofluraneinhale sevoflurane for anesthesia induction and maintenance |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- obtain informed consent;
- undergoing elective hypospadias repair surgery under general anesthesia;
- American society of anesthesiologists (ASA) class I-II;
- aged between 3-10 years old;
- BMI is 18.5-30 kg/m2;
Key exclusion criteria (9 listed)
- systolic blood pressure≥180 mmHg or<90 mmHg, diastolic blood pressure≥110 mmHg or<60 mmHg;
- serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- long-term use of hormone or a history of adrenal cortex inhibition;
- suspected or confirmed difficult airway;
- suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs;
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 |
|---|---|---|
| etomidate1. intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. 2. infusion of etomidate at 2 minutes before anesthesia induction | Drug | etomidate group |
| propofol1. intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. 2. infusion of propofol at 2 minutes before anesthesia induction | Drug | propofol group |
| sevoflurane1. intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. 2. inhale sevoflurane for anesthesia induction and maintenance | Drug | sevoflurane group |
Primary outcome
the amount of drugs
Time frame: from the beginning of induction to Bispectral Index < 50,up to 5 minutes
the amount of etomidate,propofol and sevoflurane used in anesthesia induction
the drugs used time
Time frame: from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute
the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction
numbers of muscular fibrillation
Time frame: from the beginning of induction to Bispectral Index < 50,up to 5 minutes
numbers of muscular fibrillation in anesthesia induction
degree of inflammation reaction
Time frame: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation
serum levels of interleukin 6 and tumor necrosis factor α will be measured at each time point using ELISA method
adrenal function
Time frame: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation
serum level of cortisol will be measured at each time point using radioimmunoassay
2 secondary outcomes
hemodynamic parameters
Time frame: from the beginning of induction to skin closure, up to 3 hours
sedation degree
Time frame: from the beginning of induction to skin closure, up to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Related trials for Bispectral Index
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Recruiting
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Depth of Anesthesia Monitoring, BIS-EEG
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.
Enqiang Chang contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etomidate, propofol and sevoflurane in people with Bispectral Index and Pediatric, run by Henan Provincial People's Hospital.
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 5 inclusion and 9 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Enqiang Chang (clinicaltriallh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of drugs (time frame: from the beginning of induction to Bispectral Index < 50,up to 5 minutes). The study lists 5 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 8 Jul 2014.