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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Joseph D. Tobias, 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.

Condition or disease Intervention/treatment Phase
Neuromuscular Scoliosis Drug: Clevidipine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Clevidipine

Arm Intervention/treatment
Active Comparator: Clevidipine Drug: Clevidipine



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645111


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Joseph Tobias, MD Nationwide Children's Hospital
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Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01645111    
Other Study ID Numbers: IRB12-00261
First Posted: July 20, 2012    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Scoliosis
Hypotension
Vascular Diseases
Cardiovascular Diseases
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Clevidipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs