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

• ClinicalTrials.gov Identifier: NCT01645111
• Recruitment Status: Completed
• First Posted: July 20, 2012
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015
• Sponsor: Nationwide Children's Hospital
• Information provided by (Responsible Party): Joseph D. Tobias, Nationwide Children's Hospital

Tracking Information

• First Submitted Date: June 8, 2012
• First Posted Date: July 20, 2012
• Results First Submitted Date: February 3, 2015
• Results First Posted Date: February 18, 2015
• Last Update Posted Date: February 18, 2015
• Study Start Date: June 2012
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2015)

Time to Achieve Target MAP [ Time Frame: First 30 minutes of infusion ]

The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg

Original Primary Outcome Measures (submitted: July 19, 2012)

Blood pressure [ Time Frame: Every 30 minutes during surgery, an average of 4-6 hours ]

Change in blood pressure

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
• Official Title: An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
• 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 Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neuromuscular Scoliosis
• Intervention: Drug: Clevidipine

Study Arms

Active Comparator: Clevidipine

Intervention: Drug: Clevidipine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2012): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01645111
• Other Study ID Numbers: IRB12-00261
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Nationwide Children's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph Tobias, MD; Nationwide Children's Hospital

• PRS Account: Nationwide Children's Hospital
• Verification Date: February 2015