DeliriumPhase 4NCT02644980
Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery
A Phase 4 study testing Propofol, Etomidate and Bispectral Index Monitor in people with Delirium and Hemodynamic Instability, run by Xijing Hospital.
Trial summary
For patients requiring the heart valve replacement surgery, heart function is injured in different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Delirium, Hemodynamic Instability
- What is being tested?
- Propofol, Etomidate and Bispectral Index Monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Aug 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~75 years old
- Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery
- Received heart surgery for the first time
- New York Heart Association(NYHA) II~III
- Written informed consent -
Who cannot join
- Emergency surgery
- Anticipated survival time <1 yrs
- Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection
- Prolonged use of hormone or history of adrenal suppression disease
- Severe mediastinal fiber thickening or fibrous adhesions
- Allergy to experimental drug or other contraindications
Show all 13Show fewer
- Occurred or expected occurring of difficulty airway
- Sure or suspected narcotic analgesics abuse
- History of neuro-muscular disease
- Mental instability or metal disease
- Pregnancy or brest-feeding
- Participated other clinical trial past 30 days
- Malignant hyperthermia
About this study
Official title: Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study
For patients requiring the heart valve replacement surgery, heart function is injured in different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. Etomidate has slight effect on the cardiovascular system, often used in the induction of anesthesia, however target controlled infusion etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.
- Conditions
- Delirium, Hemodynamic Instability
- Being tested
- Propofol, Etomidate, Bispectral Index Monitor, Induction of anesthesia, Maintenance of anesthesia
- Keywords
- Target Controlled Infusion
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
EtomidateDrug
Also called Fuerli
The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
Bispectral Index MonitorDevice
Also called BIS
BIS monitored from beginning of anesthesia induction to the end of the surgery.
Induction of anesthesiaDrug
Midazolam 0.03 mg/kg injection vein，Sufentanyl 0.5~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.
Maintenance of anesthesiaDrug
After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.
Tracheal IntubationOther
After the induction of anesthesia, Tracheal intubation is performed.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Experimental | The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60. Receives: Drug: Etomidate; Device: Bispectral Index Monitor; Drug: Induction of anesthesia; Drug: Maintenance of anesthesia; Other: Tracheal Intubation |
| Propofol | Experimental | The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60. Receives: Drug: Propofol; Device: Bispectral Index Monitor; Drug: Induction of anesthesia; Drug: Maintenance of anesthesia; Other: Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
blood pressure(systolic blood pressure and diastolic blood pressure) is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.
Measured: from the beginning of induction to the surgery over, up to 6 hrs.
Secondary outcomes (7)
Heart rate
Heart rate is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.
Measured: from the beginning of induction to the surgery over, up to 6 hrs.
Delirium
Using Confusion Assessment Method for the Intensive Care Unit(CAM-ICU) to screening of delirium.
Measured: The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation
Life quality
using the Activities of Daily Living (ADL) to assess the life quality one month after the surgery.
Measured: at the time of one month right after the surgery
Number of Participants with Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events including major adverse cardiovascular and cerebrovascular event such as cardiac infraction,stroke, acute renal failure, re-surgery,and death.
Safety Issue?: Yes
Measured: Up to 1 month
Time of recovery from anesthesia
Measured: from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes.
Bispectral index (BIS) value
BIS is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.
Measured: from the beginning of induction to the surgery over, up to 6 hrs.
onset time
The time period from TCI etomidate or propofol to the disappearance of eyelash reflex.
Measured: The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644980
- Sponsor's protocol ID
- XJZH20140722
- Status last verified
- Dec 2015
- First submitted
- 18 Aug 2014
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study
- ClinicalTrials.gov ID
- NCT02644980
- Acronym / sponsor ID
- XJZH20140722
- Conditions
- Delirium, Hemodynamic Instability
- Keywords
- Target Controlled Infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 1 Jan 2016 (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.
For patients requiring the heart valve replacement surgery, heart function is injured in different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. Etomidate has slight effect on the cardiovascular system, often used in the induction of anesthesia, however target controlled infusion etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Experimental | Drug: Etomidate, Device: Bispectral Index Monitor, Drug: Induction of anesthesia, Drug: Maintenance of anesthesia, Other: Tracheal IntubationThe initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60. |
| Propofol | Experimental | Drug: Propofol, Device: Bispectral Index Monitor, Drug: Induction of anesthesia, Drug: Maintenance of anesthesia, Other: Tracheal IntubationThe initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18~75 years old
- Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery
- Received heart surgery for the first time
- New York Heart Association(NYHA) II~III
- Written informed consent -
Key exclusion criteria (13 listed)
- Emergency surgery
- Anticipated survival time <1 yrs
- Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection
- Prolonged use of hormone or history of adrenal suppression disease
- Severe mediastinal fiber thickening or fibrous adhesions
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 |
|---|---|---|
| PropofolThe initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60. | Drug | Propofol |
| EtomidateAlso: FuerliThe initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60. | Drug | Etomidate |
| Bispectral Index MonitorAlso: BISBIS monitored from beginning of anesthesia induction to the end of the surgery. | Device | Etomidate, Propofol |
| Induction of anesthesiaMidazolam 0.03 mg/kg injection vein，Sufentanyl 0.5~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given. | Drug | Etomidate, Propofol |
| Maintenance of anesthesiaAfter the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped. | Drug | Etomidate, Propofol |
| Tracheal IntubationAfter the induction of anesthesia, Tracheal intubation is performed. | Other | Etomidate, Propofol |
Primary outcome
Blood pressure
Time frame: from the beginning of induction to the surgery over, up to 6 hrs.
blood pressure(systolic blood pressure and diastolic blood pressure) is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.
7 secondary outcomes
Heart rate
Time frame: from the beginning of induction to the surgery over, up to 6 hrs.
Delirium
Time frame: The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation
Life quality
Time frame: at the time of one month right after the surgery
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 1 month
Time of recovery from anesthesia
Time frame: from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes.
Bispectral index (BIS) value
Time frame: from the beginning of induction to the surgery over, up to 6 hrs.
onset time
Time frame: The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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, Etomidate and Bispectral Index Monitor in people with Delirium and Hemodynamic Instability, run by Xijing 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 13 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 1 Jan 2016. 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?
Blood pressure (time frame: from the beginning of induction to the surgery over, up to 6 hrs.). 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 1 Jan 2016.