The purpose of this study is to determine the effectiveness of prophylactic administration of intra-thecal nicardipine though lumbar cerebrospinal fluid drain in prevention of symptomatic vasospasm in patients with subarachnoid hemorrhage due to rupture of cerebral aneurysms.
Age ≥18 years
Aneurysmal subarachnoid hemorrhage with Hunt and Hess score 3 or less
Patient or legal authorized representative available to sign the informed consent form
Pre-morbid modified Rankin scale of 0 or 1.
Pregnant females
Subarachnoid hemorrhage (SAH) with hunt and hess scale of >3
SAH due to etiology other than aneurysmal rupture
Any contraindications in patients receiving calcium channel antagonists like hypersensitivity to dihydropyridines
Parallel
Normal Saline
Drug10 mL preservative-free normal saline in luer-lock sterile syringe every 24 hours from randomization through day 14 post-bleed or lumbar drain removal, whichever occurs first.
Nicardipine
DrugNicardipine 4 mg will be diluted in preservative-free normal saline to 10 mL in luer-lock sterile syringe every 24 hours from randomization through day 14 post-bleed or lumbar drain removal, whichever occurs first.
Incidence of Vasospasm
The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
Incidence of Delayed Cerebral Ischemia
The incidence of symptomatic clinical or radiographic delayed cerebral ischemia in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
Modified Rankin Scale Score
The Modified Rankin Scale is a clinical tool used to assess the functional disability after a stroke. It is a six-point ordinal scale that measures the patient's ability to perform activities of daily living. Score Range: 0 no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, 6 dead.
Incidence of Meningitis
Incidence of meningitis as confirmed by clinical and laboratory findings
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
