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 ]
  

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).