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
(6).