To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.
Age 18-80.
Spontaneous SAH confirmed by head CT.
Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
SAH Fisher grade >1 or modified Fisher grade >0.
Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
History of head trauma within the past 3 months.
Parallel
Intrathecal Nicardipine
DrugFirst, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then the EVD or LD tube is clamped for 2 hours, and then kept open as clinically necessary until the next dose (q12h) of medication.
No intervention
Other interventionA simulated "intrathecal administration" operation is performed by a dedicated physician who is unblinded to the group assignment, the EVD or LD tube is not opened, and no "drug" is given. The simulated administration process needs to be out of the patient's view (if awake patient) and out of the presence of study team personnel.
Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6
The percentage of patients with mRS 0-2
Extended Glasgow Outcome Score (GOS-E).
Minimum score 1 and maximum score 8 with higher number being better outcome
Modified Rankin Scale ordinal shift with mRS 5 and 6 combined
Shift analysis looks at transitions across different levels of mRS score, shifting from higher score to lower score means favorable outcome
Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6
The percentage of patients with mRS 0-3
Mini-Mental State Examination (MMSE) score
Minimum score 0 and maximum score 30 with higher score being better outcome
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