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

Phase

Condition

Stress

Circulation Disorders

Gliomas

Treatment

N/A

Clinical Study ID

NCT00952081

08-745

Ages > 21
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Patients with acute cardiac ischemia, renal or liver dysfunction, unstablehemodynamic, advanced heart block, or pregnancy defective lipid metabolism such aspathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompaniedby hyperlipidemia; and in patients with severe aortic stenosis will be excluded.
Known or suspected allergy to study drug or study drug components,patients withallergies to soybeans, soy products, eggs, or egg products; Participation in otherclinical research studies involving the evaluation of other investigational drugs ordevices within 30 days of enrollment in this study.

Study Design

July 01, 2009

February 28, 2010

Study 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 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 (6).

Connect with a study center

NYU Langone Medical Center, Department of Anesthesiology
New York, New York 10016
United States
Site Not Available

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