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Completed

NCT Number: NCT06098209

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Propofol

Drug

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

Primary outcomes

  1. The level of salivary alpha-amylase.

    Time frame: 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 outcomes

  1. Duration of mechanical ventilation

    Time frame: 28 days after intervention

    Time till weaning from mechanical ventilation

  2. Intensive care unit length of stay

    Time frame: 28 days after intervention

    Time from admission till intensive care discharge

  3. Heart rate

    Time frame: 2 days after intervention

    Heart rate (HR) will be recorded every 6 hours for 2 days.

  4. Mean arterial pressure

    Time frame: 2 days after intervention

    Mean arterial pressure (MAP) will be recorded every 6 hours for 2 days.

  5. Adverse events

    Time frame: 2 days after intervention

    Adverse events Such as hypotension and bradycardia will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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