Phase 3 N=50 Treatment

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

Neuromuscular Scoliosis

Bottom Line

View on ClinicalTrials.gov: NCT01645111 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Time to Achieve Target MAP — 9.2 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Clevidipine (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Nationwide Children's Hospital
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Achieve Target MAP	9.2	—

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01645111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.