Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br> | Drug: propofol<br>* 5-80 mcg/kg/min<br>|
| Experimental: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* 0.2-1.5 mcg/kg/hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes between serum and CSF cytokines over 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). | 0, 24 and 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedative and analgesic medication requirements | 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. | 2 weeks | 
| Sedation scores (RASS and CAM-ICU) |  | 2 weeks | 
| ICU length of stay |  | 2 weeks | 
| Hospital length of stay |  | 2 weeks | 
| Glasgow Outcome Scores Extended (GOSE) at discharge |  | 2 weeks | 
| Incidence of delayed cerebral ischemia (DCI) |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysmal subarachnoid hemorrhage, dexmedetomidine, cytokines