Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 2
- 主要终点
- Correlation between pupillary diameter (PD) and pain assessment
研究概览
简要总结
Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. But, cooperation of the patient is limited by cultural differences, language barriers or residual effect of products used while general anesthesia.
A lot of study were conducted to demonstrate and to quantify the pain after an operation. The aim will be dose analgesic treatment better without cooperation of the patient.
This sudy concerns patients on the post anesthesia care units one hour after their arrival. They will have electrocardiogram and video-pupillometer.
详细描述
Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too, Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to demonstrate a correlation between the three parameters.
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
- •Major patients
- •Patients fluent in French
- •Patient admitted on the post anesthesia care units
- •Exclusion criteria:
- •Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
- •Emergency operation
- •Heart rhythm disorders
- •Pacemaker
排除标准
- 未提供
研究组 & 干预措施
Patients have a surgical operation
Patients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer.
干预措施: Video-pupillometer (Other)
Patients have a surgical operation
Patients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer.
干预措施: Electrocardiogram (Other)
结局指标
主要结局
Correlation between pupillary diameter (PD) and pain assessment
时间窗: 1 hour post surgery
Correlation between pupillary diameter (PD) and pain in the post-operative period. PD will be measured by video-pupillometer. Pain will be measured by Visual Analog Scale (VAS).
次要结局
- Correlation between pupillary diameter (PD) and heart rate(1 hour post surgery)