Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation: A Randomized Pupillometry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Opioid consumption
研究概览
简要总结
The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ear nose throat (ENT) surgery.
详细描述
Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.
Background The evaluation of pain intensity during the immediate postoperative period in the operating room (OR) is a key factor for post interventional pain treatment. However, this evaluation may be difficult when patients are still intubated, restricted in consciousness or are showing verbal impairment due to ENT surgery. Verbally impaired patients are at increased risk of under treatment for pain.
With rising opioid consumption, the risk of postoperative side effects like nausea and vomiting, sedation with a longer recovery time or respiratory depression increases. Especially in the cohort of ENT surgery patients, where a difficult airway is regularly presented, such side effects should be avoided. A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable.
The pupillary dilatation reflex (PDR), measured by pupillometry, has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale (NRS).
Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) physical status I-II
- •able to read and understand the information sheet and to sign the consent form
- •being scheduled for elective ENT surgery under general anesthesia
- •age≥18 years
排除标准
- •ASA physical status of III and above
- •previous history of either drug or alcohol abuse
- •difficulty to understand pain scoring system
- •chronic users of analgesics or had used opioids within 12 h before surgery
- •drug or alcohol abuse
- •contraindications for metamizole
- •preoperative topical eye medication (atropine, phenylephrine), preoperative pupil abnormality
- •concomitant treatment with beta-antagonists, metoclopramide or droperidol
- •implanted electronic medical devices
- •dysfunction of the autonomic nervous system in relation to advanced diabetes mellitus
- •ophthalmologic diseases, known pupil reflex disorders, cranial nerve lesions
- •rapid sequence induction (RSI)
- •neurological, psychiatric or mental disorders
- •surgical procedure warranting elective postoperative ventilation
结局指标
主要结局
Opioid consumption
时间窗: first 2 postoperative hours
cumulative opioid consumption within first 2 postoperative hours
次要结局
- postoperative pain intensity(first 2 postoperative hours)
研究者
Marita Windpassinger M.D.
Principal Investigator
Medical University of Vienna