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[A controlled, double-blind, randomized pilot clinical trial of nicardipine as compared with a placebo in patients with moderate or severe head injury]

Author(s): Sahuquillo J, Robles A, Poca A, Ballabriga A, Mercadal J, Secades JJ

Affiliation(s): Servicio de Neurocirugia, Hospital de Traumatologia, Espana.

Publication date & source: 2000-03-01, Rev Neurol., 30(5):401-8.

Publication type: Clinical Trial; Randomized Controlled Trial

INTRODUCTION: One of the factors involved in the occurrence of ischemic cerebral lesions following head injury is cerebral vasospasm. We analyze the effect of intravenous nicardipine on the prevention and treatment of posttraumatic cerebral vasospasm. PATIENTS AND METHODS: We made a placebo-controlled, randomised, double-blind pilot study of the effect of nicardipine (intravenously 5 mg/hour for one week) on patients with moderate or severe head injury who presented with cerebral vasospasm, defined as an average Doppler flow velocity (DFV) of 100 cm/second or more. The main variable assessed was the evolution of the DFV and the secondary criteria were the evolution of the arterial blood pressure, coma scales, the findings on the Glasgow Coma Scale and the safety of the drug. RESULTS: Eleven patients were included in each homogeneous group. The DFV was found to have become normal on the first day of treatment with nicardipine and on the third day with the placebo (p = 0.023). During the first day of treatment the percentage of cerebral hemispheres diagnosed as having suspected spasm was 11.1% for nicardipine and 64.3% for the placebo (p = 0.02881). The average time for recovery (DFV < 100 cm/second) was 3.33 days with the placebo and 1.22 days with nicardipine (p = 0.0039). The patients treated with nicardipine had 8.89 times more chance of recovery from vasospasm. The incidence of adverse effects was greater with the placebo (p = 0.014). CONCLUSION: Nicardipine is effective in the reversal and prevention of increased Doppler flow velocity in patients with moderate or severe head injury.

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