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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2024-04-11

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.

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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.

Conditions

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Dexmedetomidine Propofol Mechanical Ventilation Salivary Alpha Amylase Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group D (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 Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Group P (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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No