Effect of nimodipine on the outcome of patients after aneurysmal subarachnoid hemorrhage and surgery.

The effect of intravenous nimodipine on the incidence of mortality and delayed ischemic neurological deficits of patients after aneurysmal subarachnoid hemorrhage (SAH) and surgery was studied in a prospective double-blind placebo-controlled trial. Upon admission, all of the patients were in Grades I to III according to the classification of Hunt and Hess. Of the 213 patients enrolled in the study, 58 underwent early surgery (within 72 hours after the bleed: Days 0 to 3), 69 were operated on subacutely (between Days 4 and 7), and 74 had late surgery (on Day 8 or later). Eleven patients died before surgery was undertaken and one was not scheduled for operation. Administration of the drug was started immediately after the radiological diagnosis of a ruptured aneurysm had been made. The dose of nimodipine or matching placebo was 0.5 micrograms/kg/min via continuous intravenous infusion for 7 to 10 days after the SAH and, if the patient was operated on late, for 2 to 3 days after the operation as well. After intravenous treatment, oral administration of nimodipine or placebo was continued for up to 21 days after SAH in a dose of 60 mg every 4 hours. Nimodipine treatment was associated with a significant decrease in mortality rate (p = 0.03) in the early and subacute surgery groups. In the total series the number of deaths due to delayed ischemic deterioration was significantly lower in the nimodipine group than in the placebo group (p = 0.01).

RCT Entities:   Population Interventions Outcomes