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OpenTrials
Completed

NCT Number: NCT01645111

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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:

  • Intravenous or oral premedication with midazolam
  • Inhalational or intravenous induction based on the preference of the patient
  • Facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula
  • 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.
  • Tranexamic acid to limit intraoperative bleeding
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

clevidipine

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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