Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Respiratory depression
研究概览
简要总结
The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.
详细描述
As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) class 1-2
- •At least 10 years of age and not older than 18 years of age
- •Diagnosis of idiopathic adolescent scoliosis
排除标准
- •Currently pregnant
- •Currently breastfeeding
- •Currently being treated with opiates
- •Currently being treated with alpha2 agonists
- •Currently being treated with anticonvulsants
- •Currently being treated with antidepressants
- •History of significant restrictive lung disease
研究组 & 干预措施
Anesthesia optimization
Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)
干预措施: pharmacokinetic simulation (Other)
结局指标
主要结局
Respiratory depression
时间窗: 24 hours
Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.
4-Item Pain Intensity Measure
时间窗: 24 hours
0 - 10 (0=no pain; 10 = pain as bad as can be)
次要结局
- Utility of pharmacokinetic simulation(4 - 8 hours (Intraoperative period))