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

Phase 2

Completed

• Conditions: Neuromuscular Scoliosis
• Interventions: Drug: Clevidipine

• Registration Number: NCT01645111
• Lead Sponsor: Nationwide Children's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Results First Submitted: 2015-02-03
• Results First Submitted QC: 2015-02-03
• Last Update Submitted: 2015-02-03
• Results First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clevidipine	Clevidipine	-

Primary Outcome Measures

Name	Time	Method
Time to Achieve Target MAP	First 30 minutes of infusion	The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States