An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
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:
- 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.
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
- 否
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
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
Joseph D. Tobias
Chairman, Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital
