Status:
COMPLETED
A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
The Medicines Company
Conditions:
Hypertension
Brain Tumor
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Clevidipine, a recently introduced, short-acting, vascular-selective calcium antagonist, could be a potentially useful adjuvant for neurosurgical cases. It decreases arterial blood pressure by reducin...
Eligibility Criteria
Inclusion
- Age 21 or older
- Able to give consent
- No significant laboratory abnormalities
- Undergoing elective surgery for tumor resection or epilepsy focus resection
Exclusion
- Patients with acute cardiac ischemia, renal or liver dysfunction, unstable hemodynamic, advanced heart block, or pregnancy defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis will be excluded.
- Known or suspected allergy to study drug or study drug components,patients with allergies to soybeans, soy products, eggs, or egg products; Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment in this study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00952081
Start Date
July 1 2009
End Date
February 1 2010
Last Update
February 9 2015
Active Locations (1)
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1
NYU Langone Medical Center, Department of Anesthesiology
New York, New York, United States, 10016