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临床试验/NCT01645111
NCT01645111已完成2 期

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

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Time to Achieve Target MAP

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Spinal fusion for neuromuscular scoliosis.

排除标准

  • 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)

研究组 & 干预措施

Clevidipine

Active Comparator

干预措施: Clevidipine (Drug)

结局指标

主要结局

Time to Achieve Target MAP

时间窗: First 30 minutes of infusion

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph D. Tobias

Chairman, Dept. of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

研究点 (1)

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