An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Treatments: Clevidipine

Criteria

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)