Target Controlled InfusionPhase 4NCT02174120
The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries
A Phase 4 study testing propofol and etomidate in people with Target Controlled Infusion and General Anesthesia, run by Henan Provincial People's Hospital.
Trial summary
To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Target Controlled Infusion, General Anesthesia
- What is being tested?
- propofol and etomidate
- 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 Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form
Who cannot join
- Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
About this study
To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.
- Conditions
- Target Controlled Infusion, General Anesthesia
- Being tested
- propofol, etomidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
etomidateDrug
Also called Fu Er Li
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | During maintenance of anesthesia, etomidate was give by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml to keep bispectral index between 40 to 60. Receives: Drug: etomidate |
| Group B | Experimental | During maintenance of anesthesia, Propofol was give by target controlled infusion, the effect-site concentration is 2 to 4 micrograms/ml to keep bispectral index between 40 to 60. Receives: Drug: propofol |
| Group C | Experimental | During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60. Receives: Drug: propofol; Drug: etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Measured: Baseline to the end of the operation, expected to be about 6 h
Blood pressure
Blood pressure should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Measured: Baseline to the end of the operation, expected to be about 6 h
Concentration of cortisol
Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over.
Measured: from baseline to the end of the operation, expected to be about 6 h
Secondary outcomes (8)
Use of vasoactive agent
The name and dose of the vasoactive agents used from the beginning of induction to the end of operation.
Measured: from the beginning of induction to the end of the operation, expected to be about 6 h
The time from stop of remifentanil to awake
Measured: The time from stop of remifentanil to awake, expected to no more than 15 min
Severity of agitation
Measured: Within 24 h after the operation
Postoperative nausea and vomiting
Measured: Within 24 h after the operation
Dose of etomidate and propofol
Measured: From the beginning of induction to the end of the operation, expected to be about 6 h
Intraoperative awareness
Measured: From the beginning of induction to the end of the operation, expected to be about 6 h
Expense of anesthetics
Measured: From the beginning of induction to the end of the operation, expected to be about 6 h
Allergic reaction
Measured: From beginning of induction to 24 h after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Target Controlled InfusionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu He, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174120
- Sponsor's protocol ID
- 20140623
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries
- ClinicalTrials.gov ID
- NCT02174120
- Acronym / sponsor ID
- 20140623
- Conditions
- Target Controlled Infusion, General Anesthesia
- 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
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Jun 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.
To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: etomidateDuring maintenance of anesthesia, etomidate was give by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml to keep bispectral index between 40 to 60. |
| Group B | Experimental | Drug: propofolDuring maintenance of anesthesia, Propofol was give by target controlled infusion, the effect-site concentration is 2 to 4 micrograms/ml to keep bispectral index between 40 to 60. |
| Group C | Experimental | Drug: propofol, Drug: etomidateDuring maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form
Key exclusion criteria (1 listed)
- Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
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 |
|---|---|---|
| propofol | Drug | Group B, Group C |
| etomidateAlso: Fu Er Li | Drug | Group A, Group C |
Primary outcome
Heart rate
Time frame: Baseline to the end of the operation, expected to be about 6 h
Heart rate should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Blood pressure
Time frame: Baseline to the end of the operation, expected to be about 6 h
Blood pressure should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Concentration of cortisol
Time frame: from baseline to the end of the operation, expected to be about 6 h
Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over.
8 secondary outcomes
Use of vasoactive agent
Time frame: from the beginning of induction to the end of the operation, expected to be about 6 h
The time from stop of remifentanil to awake
Time frame: The time from stop of remifentanil to awake, expected to no more than 15 min
Severity of agitation
Time frame: Within 24 h after the operation
Postoperative nausea and vomiting
Time frame: Within 24 h after the operation
Dose of etomidate and propofol
Time frame: From the beginning of induction to the end of the operation, expected to be about 6 h
Intraoperative awareness
Time frame: From the beginning of induction to the end of the operation, expected to be about 6 h
Expense of anesthetics
Time frame: From the beginning of induction to the end of the operation, expected to be about 6 h
Allergic reaction
Time frame: From beginning of induction to 24 h after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and etomidate in people with Target Controlled Infusion and General Anesthesia, 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 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 25 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Baseline to the end of the operation, expected to be about 6 h). The study lists 3 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 25 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.