DexmedetomidineNCT06098209
Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker
A study testing Dexmedetomidine and Propofol in people with Dexmedetomidine and Propofol, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine, Propofol, Mechanical Ventilation
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Oct 2023to 11 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years old.
- Both sexes.
- Newly mechanically ventilated.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Dexmedetomidine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patient will receive dexmedetomidine 0.2-1.4 μg/kg/h.
PropofolDrug
Patient will receive propofol 0.3-4 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days after intervention
Secondary outcomes (5)
Duration of mechanical ventilation
Time till weaning from mechanical ventilation
Measured: 28 days after intervention
Intensive care unit length of stay
Time from admission till intensive care discharge
Measured: 28 days after intervention
Heart rate
Heart rate (HR) will be recorded every 6 hours for 2 days.
Measured: 2 days after intervention
Mean arterial pressure
Mean arterial pressure (MAP) will be recorded every 6 hours for 2 days.
Measured: 2 days after intervention
Adverse events
Adverse events Such as hypotension and bradycardia will be recorded.
Measured: 2 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start24 Oct 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAhmed Mohamed Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098209
- Sponsor's protocol ID
- 36264PR353/9/23
- Status last verified
- May 2024
- First submitted
- 19 Oct 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06098209
- Acronym / sponsor ID
- 36264PR353/9/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Dexmedetomidine) | Experimental | Drug: DexmedetomidinePatient 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 P (Propofol) | Experimental | Drug: PropofolPatient 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65 years old.
- Both sexes.
- Newly mechanically ventilated.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatient will receive dexmedetomidine 0.2-1.4 μg/kg/h. | Drug | Group D (Dexmedetomidine) |
| PropofolPatient will receive propofol 0.3-4 mg/kg/h. | Drug | Group P (Propofol) |
Primary outcome
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.
5 secondary outcomes
Duration of mechanical ventilation
Time frame: 28 days after intervention
Intensive care unit length of stay
Time frame: 28 days after intervention
Heart rate
Time frame: 2 days after intervention
Mean arterial pressure
Time frame: 2 days after intervention
Adverse events
Time frame: 2 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Propofol in people with Dexmedetomidine and Propofol, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of salivary alpha-amylase. (time frame: 2 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.