drugset / Trial / NCT00952081

A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

NCT00952081

Phase 4 Completed 22 enrolled NYU Langone Health The Medicines Company · collab
NaSingle-groupOpen-labelTreatment

Summary

This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients undergoing intracranial procedures, and gather information on the dosage and adverse effects of Clevidipine in neurosurgical patients. This initial pilot experience serves to familiarize the investigators with the use of this drug prior to initiating a planned randomized trial versus institutional standard-of-care therapy. The investigators will obtain greater familiarity with the dosing of clevidipine in this patient population and collect information on the incidence of adverse effects.

Timeline

Start
2009-07
Primary completion
2009-12
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Clevidipine Small molecule 5 mg Intravenous