Safety of Dexmedetomidine SedationPhase 4NCT02225210
Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients
A Phase 4 study testing Dexmedetomidine, Midazolam and Fentanyl in people with Safety of Dexmedetomidine Sedation, run by Fuling Central Hospital of Chongqing City.
Trial summary
This study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Safety of Dexmedetomidine Sedation
- What is being tested?
- Dexmedetomidine, Midazolam and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jul 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Intensive care unit patients who need mechanical ventilation
- Anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96 hours prior to giving investigational products
- Acute physiology and chronic health evaluation II score more than 10
- Aged between 60 to 80 years old
- Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight
Who cannot join
- Trauma and burn patients
- Any kind of dialysis
- Suspected or confirmed difficult airway
- Use of neuromuscular blocking drugs(Except using for intubation )
- Neuromuscular disease
- Epidural or subarachnoid anesthesia
Show all 19Show fewer
- Plan to give general anesthesia before 24 hours drugs intervention or after giving investigational drugs
- Serious central nervous system disease
- Mental disability or mental disease
- Acute hepatitis and serious liver disease(Child-Pugh C)
- Unstable angina and acute myocardium infarction
- Left ventricular ejection volume less than 30%,heart rate less than 50 beats per minute
- II and III degree atrioventricular block
- Systolic pressure less than 90 mmHg after giving vasopressors twice before beginning of this study
- Consciousness disturbance patients whose blood pressure less than 70mmHg and blood lactate more than 4.0mmol/L
- Suspected or confirmed long term use of narcotic analgesics
- Subjects who are breastfeeding or pregnant
- Allergic to investigational products or with other contraindication
- Participated in other study within 30 days
About this study
Official title: Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial
This study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine.
- Conditions
- Safety of Dexmedetomidine Sedation
- Being tested
- Dexmedetomidine, Midazolam, Fentanyl
- Keywords
- Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Loading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.
MidazolamDrug
Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4
FentanylDrug
Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4
| Study group | Role | What they receive |
|---|---|---|
| Group dexmedetomidine ,dexmedetomidine | Experimental | Continuous pump infusion dexmedetomidine with loading dose of 0.4μg.kg-1 for 10 minutes ,then followed by maintenance dose of 0.2~0.7µg.kg-1 to maintain Sedation-Agitation Scale between 3 and 4. Receives: Drug: Dexmedetomidine |
| Group midazolam,midazolam,fentanyl | Active comparator | Quickly inject midazolam and fentanyl with loading dose of 0.1mg.kg-1 and 1 μg.kg-1 separately until attaining Sedation-Agitation Scale between 3 and 4,then followed by maintenance dose of 0.05~0.1mg.kg-1.h-1 and fentanyl 0.5~1μg.kg-1.h-1 separately. Receives: Drug: Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure within 48 hours after drug intervention
Measured: Within 48 hours after drug intervention
Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg
Measured: within 48 hours afer drug intervention
The number of cases who develop delirium
Measured: Within 48 hours after drug intervention
Secondary outcomes (3)
Changes in heart rate
Measured: Within 48 hours after drug intervention
Changes in respiratory rate
Measured: Within 48 hours after drug intervention
Changes in central venous pressure
Measured: Within 48 hours after drug intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of Dexmedetomidine SedationStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuling Central Hospital of Chongqing City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuaiya, Fuling Central Hospital of Chongqing City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225210
- Sponsor's protocol ID
- Shu 2014
- Status last verified
- Aug 2014
- First submitted
- 22 Aug 2014
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT02225210
- Acronym / sponsor ID
- Shu 2014
- Conditions
- Safety of Dexmedetomidine Sedation
- Keywords
- Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fuling Central Hospital of Chongqing CityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 26 Aug 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 study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group dexmedetomidine ,dexmedetomidine | Experimental | Drug: DexmedetomidineContinuous pump infusion dexmedetomidine with loading dose of 0.4μg.kg-1 for 10 minutes ,then followed by maintenance dose of 0.2~0.7µg.kg-1 to maintain Sedation-Agitation Scale between 3 and 4. |
| Group midazolam,midazolam,fentanyl | Active comparator | Drug: Midazolam, Drug: FentanylQuickly inject midazolam and fentanyl with loading dose of 0.1mg.kg-1 and 1 μg.kg-1 separately until attaining Sedation-Agitation Scale between 3 and 4,then followed by maintenance dose of 0.05~0.1mg.kg-1.h-1 and fentanyl 0.5~1μg.kg-1.h-1 separately. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Intensive care unit patients who need mechanical ventilation
- Anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96 hours prior to giving investigational products
- Acute physiology and chronic health evaluation II score more than 10
- Aged between 60 to 80 years old
Key exclusion criteria (19 listed)
- Trauma and burn patients
- Any kind of dialysis
- Suspected or confirmed difficult airway
- Use of neuromuscular blocking drugs(Except using for intubation )
- Neuromuscular disease
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 |
|---|---|---|
| DexmedetomidineLoading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4. | Drug | Group dexmedetomidine ,dexmedetomidine |
| MidazolamLoading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4 | Drug | Group midazolam,midazolam,fentanyl |
| FentanylLoading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4 | Drug | Group midazolam,midazolam,fentanyl |
Primary outcome
Changes in blood pressure within 48 hours after drug intervention
Time frame: Within 48 hours after drug intervention
Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg
Time frame: within 48 hours afer drug intervention
The number of cases who develop delirium
Time frame: Within 48 hours after drug intervention
3 secondary outcomes
Changes in heart rate
Time frame: Within 48 hours after drug intervention
Changes in respiratory rate
Time frame: Within 48 hours after drug intervention
Changes in central venous pressure
Time frame: Within 48 hours after drug intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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 Dexmedetomidine, Midazolam and Fentanyl in people with Safety of Dexmedetomidine Sedation, run by Fuling Central Hospital of Chongqing City.
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 6 inclusion and 19 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 26 Aug 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?
Changes in blood pressure within 48 hours after drug intervention (time frame: Within 48 hours after drug intervention). 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 26 Aug 2014.