DeliriumPhase 4NCT02080169
Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
A Phase 4 study testing midazolam, Dexmedetomidine and Fentanyl in people with Delirium, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- midazolam, Dexmedetomidine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2014
- 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
- ICU patients needing sedation
- 18 years or older
- mechanically ventilated for less than 96 hours prior to start of study drug.
Who cannot join
- Trauma and burn patients as admitting diagnosis.
- Dialysis of all types.
- Pregnant or lactation.
- Neuromuscular blockade other than for intubation.
- Epidural or spinal analgesia.
- General anesthesia prior to or planned after the start of study drug infusion
Show all 12Show fewer
- Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia).
- Acute hepatitis or severe liver disease (Child-Pugh class C).
- Unstable angina or acute myocardial infarction.
- Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block.
- 12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
- 14. Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department ICU, Shandong university affiliated Qilu Hospital.
Jinan, Shandong
Da W Wu, Doctor, 13791122767, wdw.55@163.com
Qian Zhai, Doctor
About this study
It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.
- Conditions
- Delirium
- Being tested
- midazolam, Dexmedetomidine, Fentanyl
- Keywords
- Intensive care unit, Mechanical ventilation, Combined sedation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Also called Liyuxi
If the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained.
If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained.
DexmedetomidineDrug
Also called Yisi
If the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained.
If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained.
FentanylDrug
Fentanyl is used as analgesic drug in order to obtain the VAS <3.
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Experimental | Initiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level. Receives: Drug: midazolam; Drug: Fentanyl |
| Dexmedetomidine | Experimental | The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level. Receives: Drug: Dexmedetomidine; Drug: Fentanyl |
| midazolam & dexmedetomidine | Experimental | Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),.
The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level. Receives: Drug: midazolam; Drug: Dexmedetomidine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total time within target sedation level
- Sedation level with RASS score is recorded every 4 hours during sedation.
- When target sedation was not obtained, sedation drug dosage changed and when adverse event needed to be treated, the sedation level is also recorded.
- The adjustment of sedation drug is recorded.
Measured: From sedation drug is used to weaning from sedation up to 28 days.
Secondary outcomes (7)
The dosage of sedation/analgesic drug
Record the induced and maintained dosage of sedation/opioid analgesic drug. The total dosage of sedation/opioid analgesic drug. The added dosage of midazolam.
Measured: From sedation/analgesic drug is used to weaning from sedation/analgesic up to 28 days.
Duration of mechanical ventilation
The duration of mechanical ventilation is recorded.
Measured: From beginning to weaning from ventilation up to 28 days..
Economic outcome
The cost of sedation drug used is recorded. The cost of mechanical ventilation is recorded. The cost of ICU residency is recorded.
Measured: From admitted to ICU until ventilation and sedation stopped and participants discharged from ICU up to 28 days.
Satisfactory of patients to ICU stay from admitted until discharged from ICU
Evaluated the satisfactory of patients to ICU. Using scores including 0 to 10. 0 presents extremely dissatisfied and 10 presents extremely satisfied.
Measured: Assessed at time of 1 week participants discharged from ICU.
Delirium
Delirium is evaluated when daily sedation interruption is done during sedation. Delirium incidence is recorded using CAM-ICU. Treatment of delirium is recorded including drug,dosage and method of administration.
Measured: From sedation drug is used to weaning from sedation, up to 28 days.
Vital signs
Heart rate(HR),main arterial pressure(MAP),respiratory rate(RR),pulse saturate of oxygen(SPO2) are recorded every 4 hours. When sedation drug dosage changed and adverse events treated,the vital signs is also recorded.
Gas blood analysis index is recorded when the daily interruption is done and when the SPO2 is less 90% or 10% decrease than normal.
Measured: From sedation drug is used to weaning from sedation, up to 28 days.
Duration of ICU stay
Record when participants discharged form ICU.
Measured: From date of admission until participants discharged from ICU up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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 Qilu Hospital of Shandong UniversityThe 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
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Association
- Responsible party
- Principal investigator, Qian Zhai, Qilu Hospital of Shandong University
- Investigators
- Da W Wu, Doctor., Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080169
- Sponsor's protocol ID
- CMAqiluICU
- Status last verified
- Mar 2014
- First submitted
- 25 Feb 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
- ClinicalTrials.gov ID
- NCT02080169
- Acronym / sponsor ID
- CMAqiluICU
- Conditions
- Delirium
- Keywords
- Intensive care unit, Mechanical ventilation, Combined sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Chinese Medical Association
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Mar 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.
It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam | Experimental | Drug: midazolam, Drug: FentanylInitiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level. |
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: FentanylThe loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level. |
| midazolam & dexmedetomidine | Experimental | Drug: midazolam, Drug: Dexmedetomidine, Drug: FentanylInitiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),. The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU patients needing sedation
- 18 years or older
- mechanically ventilated for less than 96 hours prior to start of study drug.
Key exclusion criteria (12 listed)
- Trauma and burn patients as admitting diagnosis.
- Dialysis of all types.
- Pregnant or lactation.
- Neuromuscular blockade other than for intubation.
- Epidural or spinal analgesia.
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 |
|---|---|---|
| midazolamAlso: LiyuxiIf the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained. If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained. | Drug | midazolam, midazolam & dexmedetomidine |
| DexmedetomidineAlso: YisiIf the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained. If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained. | Drug | Dexmedetomidine, midazolam & dexmedetomidine |
| FentanylFentanyl is used as analgesic drug in order to obtain the VAS <3. | Drug | Dexmedetomidine, midazolam, midazolam & dexmedetomidine |
Primary outcome
The total time within target sedation level
Time frame: From sedation drug is used to weaning from sedation up to 28 days.
1. Sedation level with RASS score is recorded every 4 hours during sedation. 2. When target sedation was not obtained, sedation drug dosage changed and when adverse event needed to be treated, the sedation level is also recorded. 3. The adjustment of sedation drug is recorded.
7 secondary outcomes
The dosage of sedation/analgesic drug
Time frame: From sedation/analgesic drug is used to weaning from sedation/analgesic up to 28 days.
Duration of mechanical ventilation
Time frame: From beginning to weaning from ventilation up to 28 days..
Economic outcome
Time frame: From admitted to ICU until ventilation and sedation stopped and participants discharged from ICU up to 28 days.
Satisfactory of patients to ICU stay from admitted until discharged from ICU
Time frame: Assessed at time of 1 week participants discharged from ICU.
Delirium
Time frame: From sedation drug is used to weaning from sedation, up to 28 days.
Vital signs
Time frame: From sedation drug is used to weaning from sedation, up to 28 days.
Duration of ICU stay
Time frame: From date of admission until participants discharged from ICU up to 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Da W Wu, Doctor. study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing midazolam, Dexmedetomidine and Fentanyl in people with Delirium, run by Qilu Hospital of Shandong University at 1 site in China.
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 3 inclusion and 12 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total time within target sedation level (time frame: From sedation drug is used to weaning from sedation up to 28 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 6 Mar 2014.