Evaluation of the Pupil Dilation Reflex (PDR) Using a Pupillary Pain Index (PPI) Stimulation Protocol in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Stimulation Intensity
研究概览
简要总结
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.
详细描述
An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients from the age of 28 days till 18 years undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
排除标准
- •History of eye deformity, invasive ophthalmologic surgery
- •Known cranial nerve(s) deficit
- •Infection of the eye
- •Predicted difficult airway management (Paediatric Difficult Airway Guidelines - Difficult Airway Society)
- •Chronic opioid use (>3 months)
- •Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
- •Preoperatively administrated benzodiazepins or antiemetics
结局指标
主要结局
Stimulation Intensity
时间窗: During pupil measurements in the perioperative period
Necessary stimulation intensity to dilate the pupil more than 13%
次要结局
- Heart rate(During PDR measurements)
- Blood pressure(During PDR measurements)
- Pupillary Pain Index score(During pupil measurements in the perioperative period)
研究者
Davina Wildemeersch
Principle investigator
University Hospital, Antwerp