Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparing the Sedative Effect of Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker: a Randomize Controlled Trial

Conditions
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Dexmedetomidine, Propofol, Mechanical Ventilation, Salivary Alpha Amylase, Stress

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years old. Both sexes. Newly mechanically ventilated. Exclusion Criteria: Patients who used inhaled steroids. Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs). Those with smoking and drinking habits. Patients on adrenoreceptor agonist or antagonist therapy. Pregnant female. Known hypersensitivity to the study drugs. Women using oral contraceptive or were in their menstrual cycle.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D (Dexmedetomidine)<br>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. | Drug: Dexmedetomidine<br>* Patient will receive dexmedetomidine 0.2-1.4 μg/kg/h.<br>|
| Experimental: Group P (Propofol)<br>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. | Drug: Propofol<br>* Patient will receive propofol 0.3-4 mg/kg/h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |