Responsiveness to Noxious Stimuli in Ventilated Intensive Care Unit (ICU) Patients With Propofol / Remifentanil Sedation Protocol by Using the Nociception Flexion Reflex (RIII Reflex) and the Pupillary Dilatation Reflex.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
研究概览
简要总结
The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients.
Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)
详细描述
Pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (mA) up to 60mA. Pupillary diameter was measured before, during and after stimulation.
Nociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5mA in increasing steps via an automated RIII (NFR) threshold tracking model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Critically ill with necessity to mechanic ventilation
- •Hospitalized at the ICU of our institution
- •Started sedation protocol (propofol/remifentanil or propofol/sufentanil)
- •Approved informed consent by family member or relative.
排除标准
- •Known eye deformity or extented ophthalmologic surgery in history
- •Severe traumatic brain injury of fulminant stroke
- •Known (poly)neuropathy of complicated diabetes
- •Need for continuously curarization
- •Hemodynamic instability
结局指标
主要结局
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
时间窗: 10 seconds after nociceptive stimulation
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
时间窗: 10 seconds after nociceptive stimulation
次要结局
- Comparison NFR and the standard of care pain assessment (behavior pain scale)(In period of routine two hourly check up by nurse)
- Comparison PDR and the standard of care pain assessment (behavior pain scale)(In period of routine two hourly check up by nurse)
研究者
Davina Wildemeersch
MD
University Hospital, Antwerp