Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 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.
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 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
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled abdominal or gynecological surgery
排除标准
- •History of eye deformity, invasive ophthalmologic surgery
- •Known cranial nerve(s) deficit
- •Infection of the eye
- •Predicted difficult airway management (DAF Guidelines)
- •Chronic opioid use (>3 months)
- •Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
- •Preoperatively administrated benzodiazepins or antiemetics
研究组 & 干预措施
PDR measurement
Two measurements of PDR perioperatively before and after opioid administration
干预措施: PDR measurement (Procedure)
结局指标
主要结局
Stimulation Intensity
时间窗: During perioperative period
Necessary stimulation intensity to dilate the pupil more than 13%
次要结局
- Systolic blood pressure(During PDR measurements)
- Pupillary Pain Index score(During perioperative period)
- Heart rate(During PDR measurements)
研究者
Davina Wildemeersch
MD
University Hospital, Antwerp