Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Incidence of Negative Postoperative Behavioral Changes
研究概览
简要总结
The main objective of the present study was to evaluate whether cerebral oxygen saturation is associated with an increase of NPOBC in pediatric patients undergoing major surgery.
详细描述
This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia. Cerebral oxygen saturation, non-invasive arterial pressure, pulse oximetry, and heart rate were recorded at the following stages of the surgical intervention: baseline, induction, intubation, surgical incision, end of surgery, and extubation. Preoperative anxiety was evaluated by using the modified Yale Preoperative Anxiety Scale, and NPOBC was determined by using the Post-Hospital Behaviour Questionnaire on 7th and 28th postoperative days. A logistic regression was created to identify factors associated with the development of NPOBC
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.
排除标准
- •Children aged below 2 or over
- •Neuropsychiatric disorder, or undergoing an emergency surgery.
结局指标
主要结局
Incidence of Negative Postoperative Behavioral Changes
时间窗: on 7th and 28th postoperative days
NPOBC was measured by using thePost-Hospital Behaviour Questionnaire.
次要结局
- Number of children with cerebral desaturation and NPOBC(on 7th and 28th postoperative days)
研究者
Estefanía Gomez Pesquera
MD Anesthesiologist
Hospital Clínico Universitario de Valladolid