Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
aneurysmal subarachnoid hemorrhage, dexmedetomidine, cytokines
Brief summary
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.
Interventions
DRUGDexmedetomidine
0.2-1.5 mcg/kg/hr
DRUGpropofol
5-80 mcg/kg/min
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Pregnancy * Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery * Allergy to dexmedetomidine * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes between serum and CSF cytokines over 48 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Sedation scores (RASS and CAM-ICU) | 2 weeks | — |
| ICU length of stay | 2 weeks | — |
| Sedative and analgesic medication requirements | 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. |
| Glasgow Outcome Scores Extended (GOSE) at discharge | 2 weeks | — |
| Incidence of delayed cerebral ischemia (DCI) | 2 weeks | — |
| Hospital length of stay | 2 weeks | — |
Countries
United States
Outcome results
None listed