Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
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ClinicalTrials.gov Identifier: NCT01565590
(Slow enrollment along with new competing studies, investigators decided to stop study)
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.
Changes between serum and CSF cytokines over 48 hours [ Time Frame: 0, 24 and 48 hours ]
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).
Secondary Outcome Measures
Sedative and analgesic medication requirements [ Time Frame: 2 weeks ]
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 ]
ICU length of stay [ Time Frame: 2 weeks ]
Hospital length of stay [ Time Frame: 2 weeks ]
Glasgow Outcome Scores Extended (GOSE) at discharge [ Time Frame: 2 weeks ]
Incidence of delayed cerebral ischemia (DCI) [ Time Frame: 2 weeks ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aneurysmal subarachnoid hemorrhage
World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
Surgical intervention with clip or coil
Placement of cerebrospinal fluid drain (lumbar or ventricular)
Mechanically ventilated at start of infusion
Hemodynamic instability (SBP < 100, HR <60, or on continuous infusion of catecholamines) at screening
Heart failure class III or IV (New York Heart Association)
Renal failure (RIFLE classification - see table below)
Liver failure (serum protein < 3 g/dL and total bilirubin > 5 mg/dL)
Known or suspected brain death
Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery