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

University of Cincinnati

Status and phase: Terminated; Phase 3

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Treatments: Drug: Dexmedetomidine; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01565590

11-11-22-01

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Propofol

Active Comparator group

Treatment:

Drug: propofol

Dexmedetomidine

Experimental group

Treatment:

Drug: Dexmedetomidine