TraumaPhase 2/3DEXsedationNCT02606409
Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
A Phase 2/3 study testing Dexmedetomidine and Propofol in people with Trauma, run by Assiut University at 1 site in Egypt.
Trial summary
Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for benzodiazepines and propofol, has been approved by the US Food and Drug Administration only for use up to 24 h in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Trauma
- 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Jun 2016
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Endotracheal Intubation
- Mechanical ventilation
- Poly traumatized
- ICU patients and estimated duration of sedation>24 h.
Who cannot join
- Patients with serious trauma in the central nervous system,
- with bleeding probably requiring surgical hemostasis,
- drug overdose within the last 30 days before study entry,
- pregnancy/lactation,
- contraindication to alpha-2-adrenoceptor agonists or antagonists,
- cardiovascular disease,
- conduction disturbances or difficulty in data collection or completing the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for benzodiazepines and propofol, has been approved by the US Food and Drug Administration only for use up to 24 h in mechanically ventilated patients. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients.
Read the detailed description
The importance of optimizing the levels of sedation in critical care has been increasingly recognized. Many intensive care experts are focusing on maintaining a targeted ''ideal'' sedation level according to the individual patient's condition to avoid adverse events such as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium, psychological problems, and increased treatment costs resulting from over sedation. Dexmedetomidine is a selective alpha-2-adrenoceptor agonist. It exerts both sedative and analgesic effects via mechanisms different from other sedatives such as midazolam and propofol, and provides sedation characterized by prompt response to stimuli with no respiratory depression. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients. The investigators will perform a prospective, single center trial to investigate the safety and efficacy of dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated ICU patients, in comparison with propofol.
- Conditions
- Trauma
- Being tested
- Dexmedetomidine, Propofol
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.
PropofolDrug
Also called Deprivan
Propofol sedation at a starting dose of 10-70 µg/kg/hour.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Dexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for >24h. Receives: Drug: Dexmedetomidine |
| Propofol | Active comparator | Propofol sedation at 10-70µg/kg/h for >24h. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0
sedation goal is to maintain Richmond Agitation Sedation Scale from -3 up to 0
Measured: 3 days
Secondary outcomes (5)
serum BUN
Assessment of the serum level of BUN.
Measured: 3-days
Serum creatinine.
Assessment of the serum level of creatinine.
Measured: 3-days
Systolic blood pressure
systolic blood pressure is measured every hour for 3- days.
Measured: 3- days.
diastolic blood pressure
diastolic blood pressure is measured every hour for 3- days.
Measured: 3- days.
heart rate
heart rate is recorded every hour for 3-days.
Measured: 3- days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606409
- Sponsor's protocol ID
- IRB00008718/1548
- Acronym
- DEXsedation
- Status last verified
- Jun 2016
- First submitted
- 12 Nov 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02606409
- Acronym / sponsor ID
- DEXsedation / IRB00008718/1548
- Conditions
- Trauma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- 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.
Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for benzodiazepines and propofol, has been approved by the US Food and Drug Administration only for use up to 24 h in mechanically ventilated patients. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients.
Detailed description
The importance of optimizing the levels of sedation in critical care has been increasingly recognized. Many intensive care experts are focusing on maintaining a targeted ''ideal'' sedation level according to the individual patient's condition to avoid adverse events such as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium, psychological problems, and increased treatment costs resulting from over sedation. Dexmedetomidine is a selective alpha-2-adrenoceptor agonist. It exerts both sedative and analgesic effects via mechanisms different from other sedatives such as midazolam and propofol, and provides sedation characterized by prompt response to stimuli with no respiratory depression. The investigators aim to compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated patients. The investigators will perform a prospective, single center trial to investigate the safety and efficacy of dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated ICU patients, in comparison with propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for >24h. |
| Propofol | Active comparator | Drug: PropofolPropofol sedation at 10-70µg/kg/h for >24h. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Endotracheal Intubation
- Mechanical ventilation
- Poly traumatized
- ICU patients and estimated duration of sedation>24 h.
Key exclusion criteria (7 listed)
- Patients with serious trauma in the central nervous system,
- with bleeding probably requiring surgical hemostasis,
- drug overdose within the last 30 days before study entry,
- pregnancy/lactation,
- contraindication to alpha-2-adrenoceptor agonists or antagonists,
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour. | Drug | Dexmedetomidine |
| PropofolAlso: DeprivanPropofol sedation at a starting dose of 10-70 µg/kg/hour. | Drug | Propofol |
Primary outcome
percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0
Time frame: 3 days
sedation goal is to maintain Richmond Agitation Sedation Scale from -3 up to 0
5 secondary outcomes
serum BUN
Time frame: 3-days
Serum creatinine.
Time frame: 3-days
Systolic blood pressure
Time frame: 3- days.
diastolic blood pressure
Time frame: 3- days.
heart rate
Time frame: 3- days.
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 23 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine and Propofol in people with Trauma, run by Assiut 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 4 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 23 Aug 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0 (time frame: 3 days). 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 23 Aug 2016.