A Pilot Observational Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Observational Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients|
- 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) [ Time Frame: intraoperatively and 90 min after surgery ] [ Designated as safety issue: No ]
- The time that is required to reduce systolic blood pressure below 130 mmHg during surgery as well as during recovery period [ Time Frame: intraoperatively and 90 min after surgery ] [ Designated as safety issue: No ]
- The dosages of clevidipine required to achieve goal of maintaining systolic blood pressure below 130 mmHg [ Time Frame: intraoperatively and 90 min after surgery ] [ Designated as safety issue: No ]
- The perioperative use of antihypertensive and vasoactive drugs (for hypertension that is not responded to clevidipine) [ Time Frame: intraoperatively and in PACU ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: clevidipine,brain tumor,hypertension
21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg. The anesthesiologist will be allowed to administer the alternative antihypertensive treatment (e.g. labetalol, hydralazine) after achieving a maximum clevidipine infusion rate.
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).
|United States, New York|
|NYU Langone Medical Center, Department of Anesthesiology|
|New York, New York, United States, 10016|
|Principal Investigator:||Alex Bekker, MD, PhD||NYU School of Medicine|