Status:
SUSPENDED
Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients
Lead Sponsor:
Assiut University
Conditions:
Sedation
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and dexmedetomidine infus...
Detailed Description
Available clinical evidence on the use of dexmedetomidine sedation in neurosurgical and neurocritical care is limited and no definite conclusion can be drawn. There is a need for The use of dexmedetom...
Eligibility Criteria
Inclusion
- Adult trauma patients (18-50 years old, ASA I-II).
- With and without mild TBI.
- Mild traumatic brain injury will include; brain edema, brain contusion, fracture base, fissure fracture and depressed fracture.
- The severity of traumatic brain injury will be defined as mild based on basal Glasgow Coma Scale and basal Computerized tomography scanning.
- Requirements of endotracheal intubation, mechanical ventilation and light to moderate sedation because of associated abdominal or chest traumatic injuries.
- The sedation needed should of an estimated duration not less than 24h.
- Baseline hemodynamic parameters within the normal range.
- Baseline middle cerebral artery flow velocity within the normal range.
Exclusion
- Severe traumatic brain injury, subarachnoid hemorrhage and Intra-cerebral hemorrhage.
- Spinal cord injury.
- Hemodynamically unstable patients and patients on inotropes.
- Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.
- Patients with hepatic or renal impairment.
- Pregnant females.
- Patients who are incarcerated.
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03285165
Start Date
September 14 2017
End Date
September 16 2021
Last Update
July 14 2020
Active Locations (1)
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1
Assiut university main hospital, Trauma ICU
Asyut, Assiut Governorate, Egypt, 715715