HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

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

AbstractINTRODUCTION:
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.
AuthorsJ Sahuquillo, A Robles, A Poca, A Ballabriga, J Mercadal, J J Secades
JournalRevista de neurologia (Rev Neurol) 2000 Mar 1-15 Vol. 30 Issue 5 Pg. 401-8 ISSN: 0210-0010 [Print] Spain
Vernacular TitleEnsayo clínico piloto, controlado, doblemente ciego, aleatorizado de nicardipino frente a placebo en pacientes afectados de traumatismo craneal grave o moderado.
PMID10775962 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Vasodilator Agents
  • Nicardipine
Topics
  • Adult
  • Blood Flow Velocity (physiology)
  • Blood Pressure (physiology)
  • Brain (blood supply, diagnostic imaging)
  • Brain Injuries (complications, diagnosis, drug therapy)
  • Double-Blind Method
  • Female
  • Glasgow Coma Scale
  • Humans
  • Infusions, Intravenous
  • Male
  • Nicardipine (therapeutic use)
  • Pilot Projects
  • Subarachnoid Hemorrhage, Traumatic (diagnosis, etiology)
  • Time Factors
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Vasodilator Agents (therapeutic use)
  • Vasospasm, Intracranial (diagnosis, etiology)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: