Phase 3
Completed N=50
An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
Neuromuscular Scoliosis
Source: ClinicalTrials.gov NCT01645111 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Time to Achieve Target MAP — 9.2 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Achieve Target MAP |
9.2 | — |
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)
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. Informational only — not medical advice.