Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker
- Conditions
- PropofolSalivary Alpha AmylaseDexmedetomidineMechanical VentilationStress
- Interventions
- Registration Number
- NCT06098209
- Lead Sponsor
- Tanta University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Age 18 to 65 years old.
- Both sexes.
- Newly mechanically ventilated.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group D (Dexmedetomidine) Dexmedetomidine 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) Propofol 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.
- Primary Outcome Measures
Name Time Method The level of salivary alpha-amylase. 2 days after intervention The level of salivary alpha-amylase will be measured immediately after the mechanical ventilation then after 12h for 2 days.
- Secondary Outcome Measures
Name Time Method Adverse events 2 days after intervention Adverse events Such as hypotension and bradycardia will be recorded.
Duration of mechanical ventilation 28 days after intervention Time till weaning from mechanical ventilation
Mean arterial pressure 2 days after intervention Mean arterial pressure (MAP) will be recorded every 6 hours for 2 days.
Intensive care unit length of stay 28 days after intervention Time from admission till intensive care discharge
Heart rate 2 days after intervention Heart rate (HR) will be recorded every 6 hours for 2 days.
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, El-Gharbia, Egypt