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The aim of this study is to compare the efficacy of dexmedetomidine and propofol on decreasing stress in mechanically ventilated patients by using salivary alpha-amylase as a stress marker.
Critically ill patients receiving mechanical ventilation (MV) in the Intensive Care Unit (ICU) have been reported to suffer due to their sense of dependency on technical medical equipment and from severe emotional responses such as hopelessness, anxiety, high levels of frustration and stress. The administration of sedatives is intended to reduce and/or prevent these negative experiences and to facilitate nursing care.
Dexmedetomidine is a highly selective α2 receptor agonist with 1600-fold affinity to α1 receptor. The use of dexmedetomidine before anesthesia has a positive effect on hemodynamic stability, which has been associated with reduced postoperative mortality and reduction of unpleasant postoperative complications . Dexmedetomidine has been shown to provide good patient comfort during MV; it also has a satisfactory safety profile and reduces time to extubating.
Salivary alpha amylase (SAA) will be considered as a suitable biomarker of sympathetic nervous system activity in recent years. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D (Dexmedetomidine) | Experimental | Patient will receive dexmedetomidine 0.2-1.4 μg/kg/h. Patients will be randomized to receive dexmedetomidine intravenously at rates of 0.2-1.4 μg/kg/h and 0.3-4 mg/kg/h for 2 days, respectively, to maintain the Richmond Agitation-Sedation Scale (RASS) within the range of +1 to -2. |
|
| Group P (Propofol) | Experimental | Patient will receive propofol 0.3-4 mg/kg/h. Patients will be randomized to receive propofol intravenously at rates of 0.2-1.4 μg/kg/h and 0.3-4 mg/kg/h for 2 days, respectively, to maintain the Richmond Agitation-Sedation Scale (RASS) within the range of +1 to -2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patient will receive dexmedetomidine 0.2-1.4 μg/kg/h. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The level of salivary alpha-amylase. | The level of salivary alpha-amylase will be measured immediately after the mechanical ventilation then after 12h for 2 days. | 2 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | Time till weaning from mechanical ventilation | 28 days after intervention |
| Intensive care unit length of stay | Time from admission till intensive care discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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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 |
Patient will receive propofol 0.3-4 mg/kg/h. |
|
| 28 days after intervention |
| Heart rate | Heart rate (HR) will be recorded every 6 hours for 2 days. | 2 days after intervention |
| Mean arterial pressure | Mean arterial pressure (MAP) will be recorded every 6 hours for 2 days. | 2 days after intervention |
| Adverse events | Adverse events Such as hypotension and bradycardia will be recorded. | 2 days after intervention |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |