Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
DEXsedation
1 other identifier
interventional
60
1 country
1
Brief 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. The investigators aim to compare dexmedetomidine with propofol for sedation \>24h in poly traumatized mechanically ventilated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 12, 2015
CompletedFirst Posted
Study publicly available on registry
November 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 23, 2016
June 1, 2016
7 months
November 12, 2015
August 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 days
Secondary Outcomes (5)
serum BUN
3-days
Serum creatinine.
3-days
Systolic blood pressure
3- days.
diastolic blood pressure
3- days.
heart rate
3- days.
Study Arms (2)
Dexmedetomidine
ACTIVE COMPARATORDexmedetomidine intravenous sedation at 0.2-0.7 µg/kg/h for \>24h.
Propofol
ACTIVE COMPARATORPropofol sedation at 10-70µg/kg/h for \>24h.
Interventions
Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.
Propofol sedation at a starting dose of 10-70 µg/kg/hour.
Eligibility Criteria
You may qualify if:
- Endotracheal Intubation
- Mechanical ventilation
- Poly traumatized
- ICU patients and estimated duration of sedation\>24 h.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospitals
Asyut, Assiut Governorate, 715715, Egypt
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hala S Abdel-Ghaffar, MD
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 12, 2015
First Posted
November 17, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 23, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share