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Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for benzodiazepines and propofol, has been approved by the US Food and Drug Administration only for use up to 24 h in mechanically ventilated patients. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients.
The importance of optimizing the levels of sedation in critical care has been increasingly recognized. Many intensive care experts are focusing on maintaining a targeted ''ideal'' sedation level according to the individual patient's condition to avoid adverse events such as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium, psychological problems, and increased treatment costs resulting from over sedation. Dexmedetomidine is a selective alpha-2-adrenoceptor agonist. It exerts both sedative and analgesic effects via mechanisms different from other sedatives such as midazolam and propofol, and provides sedation characterized by prompt response to stimuli with no respiratory depression. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients. The investigators will perform a prospective, single center trial to investigate the safety and efficacy of dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated ICU patients, in comparison with propofol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Dexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for >24h. |
|
| Propofol | Active Comparator | Propofol sedation at 10-70µg/kg/h for >24h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0 | sedation goal is to maintain Richmond Agitation Sedation Scale from -3 up to 0 | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| serum BUN | Assessment of the serum level of BUN. | 3-days |
| Serum creatinine. | Assessment of the serum level of creatinine. | 3-days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala S Abdel-Ghaffar, MD | Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospitals | Asyut | Assiut Governorate | 715715 | Egypt |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Propofol | Drug | Propofol sedation at a starting dose of 10-70 µg/kg/hour. |
|
|
| Systolic blood pressure | systolic blood pressure is measured every hour for 3- days. | 3- days. |
| diastolic blood pressure | diastolic blood pressure is measured every hour for 3- days. | 3- days. |
| heart rate | heart rate is recorded every hour for 3-days. | 3- days. |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |