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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 August 2016 |
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Main ID: |
NCT02606409 |
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Date of registration:
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12/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
DEXsedation |
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Scientific title:
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Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02606409 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Hala S Abdel-Ghaffar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Endotracheal Intubation
- Mechanical ventilation
- Poly traumatized
- ICU patients and estimated duration of sedation>24 h.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trauma
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Propofol
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Primary Outcome(s)
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percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0
[Time Frame: 3 days]
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Secondary Outcome(s)
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diastolic blood pressure
[Time Frame: 3- days.]
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Serum creatinine.
[Time Frame: 3-days]
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heart rate
[Time Frame: 3- days.]
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serum BUN
[Time Frame: 3-days]
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Systolic blood pressure
[Time Frame: 3- days.]
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Secondary ID(s)
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IRB00008718/1548
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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