Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.
Subarachnoid Hemorrhage, Aneurysmal
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage|
- Changes between serum and CSF cytokines over 48 hours [ Time Frame: 0, 24 and 48 hours ] [ Designated as safety issue: No ]Measure the baseline level (at enrollment) of inflammatory markers tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), glial fibrially acidic protein (GFAP), and malondialdehyde (MDA) as measured in both serum and cerebrospinal fluid (CSF) in 10 patients with aneurysmal subarachnoid hemorrhage (aSAH).
- Sedative and analgesic medication requirements [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Sedation requirements between the two groups will be assessed by comparing total daily dose and average daily fentanyl doses in the 24 hours following surgery. The total number of patients requiring propofol rescue in the dexmedetomidine group and the total daily dose and average daily dose of the propofol used in the dexmedetomidine group will be recorded.
- Sedation scores (RASS and CAM-ICU) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- ICU length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Glasgow Outcome Scores Extended (GOSE) at discharge [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Incidence of delayed cerebral ischemia (DCI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Propofol||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565590
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|