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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06098209
Enrollment
40
Registered
2023-10-24
Start date
2023-10-24
Completion date
2024-04-11
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDexmedetomidine

Patient will receive dexmedetomidine 0.2-1.4 μg/kg/h.

DRUGPropofol

Patient will receive propofol 0.3-4 mg/kg/h.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The level of salivary alpha-amylase.2 days after interventionThe level of salivary alpha-amylase will be measured immediately after the mechanical ventilation then after 12h for 2 days.

Secondary

MeasureTime frameDescription
Duration of mechanical ventilation28 days after interventionTime till weaning from mechanical ventilation
Intensive care unit length of stay28 days after interventionTime from admission till intensive care discharge
Heart rate2 days after interventionHeart rate (HR) will be recorded every 6 hours for 2 days.
Mean arterial pressure2 days after interventionMean arterial pressure (MAP) will be recorded every 6 hours for 2 days.
Adverse events2 days after interventionAdverse events Such as hypotension and bradycardia will be recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026