Clinical trial NCT02606409: Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
Official title: Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of time with in the target sedation range of Richmond Agitation Sedation Scale-3-0
timeFrame: 3 days
Secondary outcomes:
measure: serum BUN
timeFrame: 3-days
measure: Serum creatinine.
timeFrame: 3-days
measure: Systolic blood pressure
timeFrame: 3- days.
measure: diastolic blood pressure
timeFrame: 3- days.
measure: heart rate
timeFrame: 3- days.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut governorate
Study officials:
affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: