An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
The current study would prospectively evaluate the dosing requirements, efficacy and safety
 of clevidipine for controlled hypotension during spinal surgery in the pediatric population.
 As the investigators currently have projects underway which include those patients having
 scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing
 scoliosis surgery for neuromuscular disease.
This would basically be an observational study without a significant change in our current
 practice. There would be no change in the standard and usual anesthetic care including
 premedication, anesthetic induction, intraoperative anesthetic management, and intraoperative
 monitoring. Our usual anesthetic routine includes:

 1. Intravenous or oral premedication with midazolam

 2. Inhalational or intravenous induction based on the preference of the patient

 3. Facilitation of endotracheal intubation with a dose of rocuronium with placement of
 intraoperative monitors including an arterial cannula

 4. Maintenance anesthesia to include desflurane titrated to maintain the bispectral index
 at 40-60, fentanyl 2-4 µg/kg followed by a remifentanil infusion to maintain the mean
 arterial pressure at 55-65 mmHg.

 5. Tranexamic acid to limit intraoperative bleeding

 6. As needed, agent to control blood pressure to maintain the MAP at 55-65 mmHg if
 remifentanil in doses up to 0.3 µg/kg/min are ineffective.

 As needed, clevidipine will be started at 1 µg/kg/min and titrated up in 1 µg/kg/min every
 1-2 minutes to achieve an MAP at 55-65mmHg. Vital signs including heart rate will be recorded
 every 1 minute until the target MAP is achieved and then at 15 minute increments after that.
Inclusion Criteria:

 -  Spinal fusion for neuromuscular scoliosis.

 Exclusion Criteria:

 -  Allergy to dihydropyridine calcium channel antagonists

 -  Allergy to soy or eggs

 -  Non-neuromuscular causes of scoliosis

 -  Disorders of lipid metabolism (clevidipine is in a lipid base)