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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098209
• Other study ID #: 36264PR353/9/23
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2023
• Source: Tanta University
• Contact: Ahmed M Ibrahim, MD
• Phone: 00201141779238
• Email: ahmed.edib[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Mechanical Ventilation
• Propofol
• Stress

Intervention

Drug:
• Dexmedetomidine
Patient will receive dexmedetomidine 0.2-1.4 µg/kg/h.
• Propofol
Patient will receive propofol 0.3-4 mg/kg/h.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of mechanical ventilation	Time till weaning from mechanical ventilation	28 days after intervention
Secondary	Intensive care unit length of stay	Time from admission till intensive care discharge	28 days after intervention
Secondary	Heart rate	Heart rate (HR) will be recorded every 6 hours for 2 days.	2 days after intervention
Secondary	Mean arterial pressure	Mean arterial pressure (MAP) will be recorded every 6 hours for 2 days.	2 days after intervention
Secondary	Adverse events	Adverse events Such as hypotension and bradycardia will be recorded.	2 days after intervention