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To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine consistent infusion as sedative. |
|
| Midazolam group | Active Comparator | Midazolam consistent infusion as sedative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | consistent infusion at a loading dose of 0.15ug/kg/h, increased by 0.15ug/kg/h, with a maximum dose of 1.5ug/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| acute muscle wasting | measured by 3-MH release in serum | From date of randomization to extubation,up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | death rate within 28 days after mechanical ventilation | From date of randomization to date of death from any cause,up to 28 days |
| length of ICU stay | time from enrollment to discharge or die |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenkui Yu, Ph.D | Contact | 13701582986 | yudrnj@163.com | |
| Qin Gu, Master | Contact | 13705150348 | icuguqin@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affliated Drum Tower Hospital, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210008 | China |
Individual participant data is not available to other researchers after publication.
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h. |
|
| From date of randomization to date of to discharge or death,up to 28 days |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |