A prospective, open-label trial of clevidipine for controlled hypotension during posterior spinal fusion.

OBJECTIVES: Controlled hypotension is one means to limit or avoid the need for allogeneic blood products. Clevidipine is a short-acting, intravenous calcium channel antagonist with a half-life of 1 to 3 minutes due to rapid metabolism by non-specific blood and tissue esterases. To date, there are no prospective evaluations with clevidipine in the pediatric population. We prospectively evaluated the dosing requirements, efficacy, and safety of clevidipine for ontrolled hypotension during spinal surgery for neuromuscular scoliosis in the pediatric population.
METHODS: Patients undergoing posterior spinal fusion for neuromuscular scoliosis were eligible for inclusion. The study was an open label, observational study. Maintenance anesthesia included desflurane titrated to maintain a bispectral index at 40 to 60 and a remifentanil infusion. Motor and somatosensory evoked potentials were monitored intraoperatively. When the mean arterial pressure (MAP) was ≥ 65 mmHg despite remifentanil at 0.3 mcg/kg/min, clevidipine was added to maintain the MAP at 55 to 65 mmHg. Clevidipine was initiated at 0.25 to 1 mcg/kg/min and titrated up in increments of 0.25 to 1 mcg/kg/min every 3 to 5 minutes to achieve the desired MAP.
RESULTS: The study cohort included 45 patients. Fifteen patients (33.3%) did not require a clevidipine infusion to maintain the desired MAP range, leaving 30 patients including 13 males and 17 females for analysis. These patients ranged in age from 7.9 to 17.4 years (mean ± SD: 13.7 ± 2.2 years) and in weight from 18.9 to 78.1 kg (mean ± SD: 43.4 ± 14.2 kg). Intraoperatively, the clevidipine infusion was stopped in 6 patients as the surgeon expressed concerns regarding spinal cord perfusion and requested a higher MAP than the study protocol allowed. The data until that point were included for analysis. The target MAP was initially achieved at a mean time of 8.9 minutes. Sixteen of the 30 patients (53.3%) achieved the target MAP within 5 minutes. Heart rate (HR) increased from a baseline of 83 ± 16 to 86 ± 15 beats per minute (mean ± SD) (p=0.04) with the administration of clevidipine. No patient had a HR increase ≥ 20 beats per minute or required the administration of a β-adrenergic antagonist. The duration of the clevidipine administration varied from 8 to 527 minutes (mean ± SD: 160 ± 123 minutes). The maintenance infusion rate of clevidipine varied from 0.25 to 5.0 mcg/kg/min (mean ± SD: 1.4 ± 1.1 mcg/kg/min). Clevidipine was paused a total of 43 times in the 30 cases. In 18 of the 30 patients (60%), the clevidipine infusion was temporarily paused more than once due to a MAP < 55 mmHg. A fluid bolus was administered to only 1 patient to treat the low MAP. No patient required the administration of a vasoactive agent for hypotension. When the clevidipine infusion was discontinued as controlled hypotension was no longer required, the MAP returned to baseline or ≥ 65 mmHg within 10 minutes in 12 of the 30 patients (40%).
CONCLUSIONS: Clevidipine can be used to provide controlled hypotension during posterior spinal fusion. The response of the MAP, both the onset and duration of action, were rapid. Although titration of the infusion with occasional pauses of administration may be needed, excessive hypotension was not noted.