Mechanical Ventilation ComplicationPhase 4NCT02122055
Sequential Use of Propofol/Midazolam and Dexmedetomidine for Sedation in Mechenical Ventialtion Patients in ICU.
A Phase 4 study testing Fentanyl, Sedation assessment and Screen of weaning in people with Mechanical Ventilation Complication, run by Tianjin Third Central Hospital.
Trial summary
For the patient who passed the screen of weaning from ventilation, the traditional sedation drug such as propofol and midazolam should be decreased or stopped, then it would induce the stress response and agitation, such as hypertension,tachycardia etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Fentanyl, Sedation assessment and Screen of weaning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- Anticipated Ventilation and sedation duration of at least 48 hours
- Age≥18 years old
- Weight is in the range of ±20% of standard weight.[Standard weight= (Height(cm)-80)×70﹪ for male and (Height(cm)-70)×60﹪for female] -
Who cannot join
- Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite continuous infusions of vasopressors before the start of study drug infusion or shock；
- Heart rate less than 50 bpm
- Second or third degree heart block
- Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia)
- Acute hepatitis or severe liver disease (Child-Pugh class C)
- Dialysis of all types 7）History of neuromuscular disease
- 8) Unstable mental status and metal illness 9) Sure or suspected abuse of narcotics and alcohol independence 10) Allergy to experimental drug and other contraindication 11) Advanced tumor patients 12) Neuromuscular blockade other than for intubation 13) Pregnancy or lactation 14) Patient that participate other trial at past 30 days -
About this study
Official title: Sequential Use of Propofol/Midazolam and Dexmedetomidine for Sedation in Mechenical Ventialtion Patients in ICU, A Randomized Controlled Study.
For the patient who passed the screen of weaning from ventilation, the traditional sedation drug such as propofol and midazolam should be decreased or stopped, then it would induce the stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that problem, the sedation should be given again. but if renewed to sedation, it would cause prolonged sedation and ventilation duration.
So as to resolve above issues, after the patient passed the screen of weaning, sedation is changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study to compare the efficacy and safety of sequential sedation of propofol or midazolam and dexmedetomidine in mechanical ventilated ICU patients.
- Conditions
- Mechanical Ventilation Complication
- Keywords
- combined sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Fentanyl 0.7-1μg/kg，prn pain assessment is done every 4 hours，maintain Behavioral Pain Scale（BPS） 0-2.
Sedation assessmentProcedure or surgery
Sedation assessment is done every 4 hours,maintain the Riker Sedation Agitation Score(SAS) 3-4.
Screen of weaningProcedure or surgery
- Screen of weaning is done at 8:00 every morning. 2 If the patient is successful to wean, stop the Dexmedetomidine sedation. 3. If failed to wean, the patient is ventilated again and try to wean after 24 hours, until it is successful to wean and stop sedation，
PropofolDrug
Propofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained.
MidazolamDrug
Also called Liyuexi
Midazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained.
DexmedetomidineDrug
Also called Yisi
After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning.
| Study group | Role | What they receive |
|---|---|---|
| Propofol/Dexmedetomidine | Experimental | 1. Propofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained.
2. After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning. Receives: Drug: Fentanyl; Procedure: Sedation assessment; Procedure: Screen of weaning; Drug: Propofol; Drug: Dexmedetomidine |
| Midazolam/Dexmedetomidine | Experimental | 1. Midazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained.
2. After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning. Receives: Drug: Fentanyl; Procedure: Sedation assessment; Procedure: Screen of weaning; Drug: Midazolam; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation duration
The time of intubation and the time of weaning from mechanical ventilation are recorded.
Measured: From intubation to weaning from mechanical ventilation, up to 7 days.
Secondary outcomes (8)
Delirium
Using the Mini-mental State Examination(MMSE) to examine the delirium.
Measured: From the beginning of sedation to discharge from ICU, up to 28 days.
Blood pressure
blood pressure is recorded.
Measured: From the beginning to weaning of sedation, up to 7 days.
Cost of sedation drug
The cost of sedation drug is calculated.
Measured: From the admition to discharge from ICU,up to 28 days.
Cost of narcotics
Cost of narcotics is calculated.
Measured: From the admition to discharge from ICU,up to 28 days.
Cost of ICU stay
Measured: From the beginning to weaning of sedation, up to 7 days.
Heart rate
Measured: From the beginning to weaning of sedation, up to 7 days.
Respiration Rate
Measured: From the beginning to weaning of sedation, up to 7 days.
Pulse blood oxygen saturation
Measured: From the beginning to weaning of sedation, up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Third Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Association
- Responsible party
- Sponsor
- Investigators
- Jun Li, Professor, Principal investigator, Tianjin Third Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122055
- Sponsor's protocol ID
- CMATJHICU
- Status last verified
- Apr 2014
- First submitted
- 21 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Use of Propofol/Midazolam and Dexmedetomidine for Sedation in Mechenical Ventialtion Patients in ICU, A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02122055
- Acronym / sponsor ID
- CMATJHICU
- Conditions
- Mechanical Ventilation Complication
- Keywords
- combined sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Collaborators
- Chinese Medical Association
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 24 Apr 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.
For the patient who passed the screen of weaning from ventilation, the traditional sedation drug such as propofol and midazolam should be decreased or stopped, then it would induce the stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that problem, the sedation should be given again. but if renewed to sedation, it would cause prolonged sedation and ventilation duration.
So as to resolve above issues, after the patient passed the screen of weaning, sedation is changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study to compare the efficacy and safety of sequential sedation of propofol or midazolam and dexmedetomidine in mechanical ventilated ICU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol/Dexmedetomidine | Experimental | Drug: Fentanyl, Procedure: Sedation assessment, Procedure: Screen of weaning, Drug: Propofol, Drug: Dexmedetomidine1. Propofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained. 2. After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning. |
| Midazolam/Dexmedetomidine | Experimental | Drug: Fentanyl, Procedure: Sedation assessment, Procedure: Screen of weaning, Drug: Midazolam, Drug: Dexmedetomidine1. Midazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained. 2. After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written Informed Consent
- Anticipated Ventilation and sedation duration of at least 48 hours
- Age≥18 years old
- Weight is in the range of ±20% of standard weight.[Standard weight= (Height(cm)-80)×70﹪ for male and (Height(cm)-70)×60﹪for female] -
Key exclusion criteria (7 listed)
- Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite continuous infusions of vasopressors before the start of study drug infusion or shock；
- Heart rate less than 50 bpm
- Second or third degree heart block
- Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia)
- Acute hepatitis or severe liver disease (Child-Pugh class C)
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 |
|---|---|---|
| FentanylFentanyl 0.7-1μg/kg，prn pain assessment is done every 4 hours，maintain Behavioral Pain Scale（BPS） 0-2. | Drug | Midazolam/Dexmedetomidine, Propofol/Dexmedetomidine |
| Sedation assessmentSedation assessment is done every 4 hours,maintain the Riker Sedation Agitation Score(SAS) 3-4. | Procedure or surgery | Midazolam/Dexmedetomidine, Propofol/Dexmedetomidine |
| Screen of weaning1. Screen of weaning is done at 8:00 every morning. 2 If the patient is successful to wean, stop the Dexmedetomidine sedation. 3. If failed to wean, the patient is ventilated again and try to wean after 24 hours, until it is successful to wean and stop sedation， | Procedure or surgery | Midazolam/Dexmedetomidine, Propofol/Dexmedetomidine |
| PropofolPropofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained. | Drug | Propofol/Dexmedetomidine |
| MidazolamAlso: LiyuexiMidazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained. | Drug | Midazolam/Dexmedetomidine |
| DexmedetomidineAlso: YisiAfter the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning. | Drug | Midazolam/Dexmedetomidine, Propofol/Dexmedetomidine |
Primary outcome
Ventilation duration
Time frame: From intubation to weaning from mechanical ventilation, up to 7 days.
The time of intubation and the time of weaning from mechanical ventilation are recorded.
8 secondary outcomes
Delirium
Time frame: From the beginning of sedation to discharge from ICU, up to 28 days.
Blood pressure
Time frame: From the beginning to weaning of sedation, up to 7 days.
Cost of sedation drug
Time frame: From the admition to discharge from ICU,up to 28 days.
Cost of narcotics
Time frame: From the admition to discharge from ICU,up to 28 days.
Cost of ICU stay
Time frame: From the beginning to weaning of sedation, up to 7 days.
Heart rate
Time frame: From the beginning to weaning of sedation, up to 7 days.
Respiration Rate
Time frame: From the beginning to weaning of sedation, up to 7 days.
Pulse blood oxygen saturation
Time frame: From the beginning to weaning of sedation, up to 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
Jun Li, Professor principal investigator
Tianjin Third Central Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, Sedation assessment and Screen of weaning in people with Mechanical Ventilation Complication, run by Tianjin Third Central 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 4 inclusion and 7 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 24 Apr 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?
Ventilation duration (time frame: From intubation to weaning from mechanical ventilation, up to 7 days.). 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 24 Apr 2014.