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

NCT06098209 | Completed

• 1 other identifier: 36264PR353/9/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of mechanical ventilation

  28 days after intervention

• Intensive care unit length of stay

  28 days after intervention

• Heart rate

  2 days after intervention

• Mean arterial pressure

  2 days after intervention

• Adverse events

  2 days after intervention

Study Arms (2)

Group D (Dexmedetomidine)

EXPERIMENTAL

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

Group P (Propofol)

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

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

Group D (Dexmedetomidine)

Propofol DRUG

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

Group P (Propofol)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years old.
• Both sexes.
• Newly mechanically ventilated.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: October 24, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)