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

Nationwide Children's Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Neuromuscular Scoliosis

Treatments: Drug: Clevidipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01645111

IRB12-00261

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Clevidipine

Active Comparator group

Treatment:

Drug: Clevidipine