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

Phase 4
21 Years
Not Enrolling
Hypertension, Brain Tumor, Epilepsy

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Trial Information

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

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 reducing systemic vascular resistance with no effect on venous capacitance
vessels (7). Clevidipine was successfully used for the treatment of hypertension in cardiac
surgical patients (8). However, there is no information available on its efficacy and safety
in patients undergoing intracranial surgery.

The perioperative course of patients undergoing intracranial surgery is frequently
complicated by acute hypertensive episodes. Acute hypertension in neurosurgical patients is
associated with intracranial bleeds and prolonged hospital stay (1). Even with current
neuroanesthesia management, hemodynamic stability may be challenging, especially in
hypertensive patients. An anesthetic technique that improves perioperative hemodynamics
without increasing the incidence of undesirable events (such as increased intracranial
pressure, prolonged recovery, etc.) is desirable.

A number of antihypertensive agents are available to treat perioperative hypertension.
Labetalol is commonly used to treat hypertensive episodes in patients undergoing craniotomy,
but may not be desirable in certain patient populations because of its low potency, a slow
onset of peak effect (2), and unpredictability in dose requirements (3). Esmolol is only
mildly effective in treating postoperative hypertension. Perioperative use is further
complicated by bradycardia and conduction delay. Nicardipine is more effective than esmolol
in controlling postoperative hypertension (4). However, it causes a dose-dependent cerebral
vasodilation, inhibition of autoregulation, as well as a high incidence of hypotension (as
compared to labetalol) (5). Hydralazine may increase intracranial pressure by as much as
100% and is rarely used as the sole agent in treating hypertension in neurosurgical patients

Inclusion Criteria:

- Age 21 or older

- Able to give consent

- No significant laboratory abnormalities

- Undergoing elective surgery for tumor resection or epilepsy focus resection

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of this trial is the proportion of patients who did not require rescue antihypertensive medication to maintain SBP below 130 mmHg (i.e. clevidipine is a sole antihypertensive agent used for blood pressure control)

Outcome Time Frame:

intraoperatively and 90 min after surgery

Safety Issue:


Principal Investigator

Alex Bekker, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

February 2010

Related Keywords:

  • Hypertension
  • Brain Tumor
  • Epilepsy
  • Hypertension
  • Neurosurgery
  • bloodpressure control
  • brain tumor resection
  • epilepsy focus resection
  • Brain Neoplasms
  • Epilepsy
  • Hypertension



NYU Langone Medical Center, Department of Anesthesiology New York, New York  10016