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

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06098209
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine; Propofol; Mechanical Ventilation; Salivary Alpha Amylase; Stress	Drug: Dexmedetomidine; Drug: Propofol	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 24, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The level of salivary alpha-amylase. [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 Outcome Measures

1. Duration of mechanical ventilation [28 days after intervention]

   Time till weaning from mechanical ventilation

2. Intensive care unit length of stay [28 days after intervention]

   Time from admission till intensive care discharge

3. Heart rate [2 days after intervention]

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

4. Mean arterial pressure [2 days after intervention]

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

5. Adverse events [2 days after intervention]

   Adverse events Such as hypotension and bradycardia will be recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	El-Gharbia	Egypt	31527

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ِAhmed Mohamed Ibrahim, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT06098209
• Other Study ID Numbers: 36264PR353/9/23
• First Posted: Oct 24, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine; Propofol

Study Results

No Results Posted as of Oct 25, 2023