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临床试验/NCT04176289
NCT04176289已完成不适用

PPI-guided Postoperative Pain Therapy in the OR

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
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 pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.

详细描述

Abstract

The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery. Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

盲法说明

double blinded study design (participants, evaluator)

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

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
  • implanted electronic medical devices
  • ophthalmologic diseases
  • rapid sequence induction (RSI)
  • 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(first 2 postoperative hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marita Windpassinger M.D.

Principal Investigator

Medical University of Vienna

研究点 (2)

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