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

Neuromuscular Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645111
• Other study ID #: IRB12-00261
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 8, 2012
• Last updated: February 3, 2015
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Neuromuscular Scoliosis

Intervention

Drug:
• Clevidipine

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Achieve Target MAP	The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg	First 30 minutes of infusion	No