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Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow include a high incidence rate of delirium, But the combination of midazolam and dexmedetomidine may have complementary advantages and could have be a better choice for sedation. In this study, we attempted to observe the effects of two different drug regimens on delirium incidence rates in severe ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine,midazolam | Experimental | Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02~0.1mg/kg/h, for 24 hours.Dexmedetomidine will be added at 0.2~1.4μg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of dexmedetomidine, continuous intravenous infusion of midazolam could be used at 0.02~0.1mg/kg/h, until the target level is reached. |
|
| Propofol,midazolam | Active Comparator | Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02~0.1mg/kg/h, for 24 hours.Propofol will be added at 0.3~4mg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of propofol, continuous intravenous infusion of midazolam could be used at 0.02~0.1mg/kg/h, until the target level is reached. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine,midazolam | Drug |
| ||
| Propofol,midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates and duration of delirium | Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol | up to 15 days |
| Sedation interruption | Eye opening according to the voice orders, eye tracking, clenching fist and nodding are involved in assessment, patients could do 3 of those or more is deemed as conscious and taken in delirium assessment. | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation therapy effect | The frequency of assessment whose score fall within the target range. | up to 7 days |
| Hospitalized days in ICU | up to 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HeNan Tumor Hospital | Zhengzhou | Henan | 450000 | China |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Death rates | Patients' death rates with a follow-up of 28 days | 28 days |
| Incidence rate of patients self-extubation | up to 7 days |
| Injection speed, total dose and injection of sedatives in different groups. | 7 days |
| Additional dose of fentanyl and midazolam | up to 7 days |
| Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents. | up to 15 days |
| Variation degree of HR, RR, BP and SpO2 | up to 15 days |
| The Second Hospital of Shandong University | Jinan | Shandong | 250033 | China |
|
| Affiliated Hospital of Jining Medical University | Jining | Shandong | 272000 | China |
|
| Liaocheng Hospital | Liaocheng | Shandong | 252000 | China |
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| Linyi People's Hospital | Linyi | Shandong | 276000 | China |
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| Affiliated Hospital of Weifang Medical University | Weifang | Shandong | 261031 | China |
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| Central Hospital of Zibo | Zibo | Shandong | 255000 | China |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |