Status:
SUSPENDED
Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability
Lead Sponsor:
Assiut University
Conditions:
Sedation
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
Hypotension and bradycardia have been commonly associated with dexmedetomidine therapy, occurring in 13% to 68% and 1% to 42% of patients, respectively. The variability in reported incidence may be pa...
Detailed Description
Dexmedetomidine is specific for the α-2a receptor, especially at lower concentrations, resulting in both vasodilation and a blunting of the sympathetic response. Due to these mechanistic consideration...
Eligibility Criteria
Inclusion
- Adult patients (18-65 years old)
- admitted to Intensive care units in Assiut university Hospital
- requiring endotracheal intubation, mechanical ventilation and light to moderate sedation
- of an estimated duration not less than 24h.
Exclusion
- History of coronary care unit admission.
- Severe traumatic brain injury.
- Low baseline arterial blood pressure defined as SBP \<100 mm Hg or mean arterial blood pressure (MAP) \<70 mm Hg in the 60 minutes preceding dexmedetomidine initiation.
- Slow baseline heart rate was \<70 bpm in the 60 minutes preceding dexmedetomidine initiation.
- Spinal cord injury.
- Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.
- Patients who are admitted with a primary diagnosis of substance withdrawal.
- Pregnant females.
- Patients who are incarcerated.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03285087
Start Date
June 1 2021
End Date
August 1 2022
Last Update
January 14 2021
Active Locations (1)
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1
Assiut university main hospital, Trauma ICU
Asyut, Assiut Governorate, Egypt, 715715