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The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. The main question[s] it aims to answer are:
This study will include 60 patients with ARDS who will be admitted to the intensive care unit (ICU) and chest ICU of Banha university hospitals during the period between June 2023 and June 2024.
ARDS will be diagnosed based on the presence of new or worsening symptoms within one week of a known clinical insult; bilateral opacities on anteroposterior chest X-ray that are not due to effusions, nodules or lobar or lung collapse; and hypoxemia, defined as arterial oxygen tension/fraction of inspired oxygen (Pao2/FiO2) < 300 mm Hg and a minimum positive end-expiratory pressure ≥ 5 cm H2O, that is not explained by heart failure or fluid overload.
Patients were divided randomly into two groups. Group A (n = 30); received with starting dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and Group B (n = 30); received dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.
All patients will be subjected to the following:
All data will be tabulated and statistically analyzed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine plus ketamine | Active Comparator | starting intravenous infusion dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h to 30 mechanically ventilated ARDS patient |
|
| high dose dexmedetomidine | Active Comparator | dexmedetomidine at 0.5 µg/kg/h intravenous infusion only to be titrated to achieve full sedation to 30 mechanically ventilated ARDS patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine plus ketamine | Drug | titrating the dose of dexmedetomidine mixed with ketamine (staring dose 0.5ug/kg/hr, 0.5mg/kg/hr respectively)to achieve full sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| oxygenation parameter | change of PaO2/FiO2 | 24-27 hours |
| positive end expiratory pressure (PEEP) | change of PEEP parameter that need to maintain oxygen saturation above 88% | 24-27 hours |
| Measure | Description | Time Frame |
|---|---|---|
| serum level of C-reactive protein (CRP) | change of serum level of CRP (mg/dl) | 24-72 hours |
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Inclusion Criteria:
patients with ARDS with the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa Elnaggar, MD | Benha University, Faculty of medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha university | Banhā | Qalyubia Governorate | 13511 | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Dexmedetomidine | Drug | starting intravenous infusion with dexmedetomidine starting at dose 0.5ug/kg//hr and titrate the dose to achieve full sedation |
|
|
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |