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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Dexmedetomidine; Mechanical Ventilation; Propofol; Salivary Alpha Amylase
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dexmedetomidine; Patient will receive dexmedetomidine 0.2-1.4 μg/kg/h.
Experimental: 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.	Drug: Propofol; Patient will receive propofol 0.3-4 mg/kg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 36264PR353/9/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No