Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression in Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Impact of environmental stimulation on decline in oxygen saturation to ≤ 90%.
研究概览
简要总结
Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence versus absence of verbal interaction.
详细描述
Healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for 10 minutes. Vital signs including SpO2, transcutaneous CO2, and respiratory rate will be continuously measured.
In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence of ongoing verbal interaction versus complete avoidance of verbal interaction.
Incidence of respiratory depression will be compared in the two protocols with or without verbal interaction. Correlation between pupil diameter and pupillary unrest with estimated opioid concentrations will be determined by regression. Difference between pupil measurement versus opioid concentration regressions will be compared by chi2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent
排除标准
- •Active substance use disorder
- •Prior opioid use disorder
- •Opioid use within 30 days.
研究组 & 干预措施
Non-interactive
All verbal interaction will be avoided and extraneous sounds will be eliminated from the environment during the remifentanil infusion and recovery periods.
干预措施: Remifentanil infusion (Drug)
Interactive
Subject will be asked to continually interactive with the investigators, answering a series of standard questions during the remifentanil infusion and recovery periods.
干预措施: Continuous conversational interaction (Behavioral)
Interactive
Subject will be asked to continually interactive with the investigators, answering a series of standard questions during the remifentanil infusion and recovery periods.
干预措施: Remifentanil infusion (Drug)
结局指标
主要结局
Impact of environmental stimulation on decline in oxygen saturation to ≤ 90%.
时间窗: 35 minutes
Conversational interaction and oxygen saturation measured by pulse oximeter.
Impact of environmental stimulation on CO2 increase of 15% or more above baseline.
时间窗: 35 minutes
Conversational interaction and CO2 measured by transcutaneous sensor.
Correlation between estimated opioid concentration and deviation in pupillary measurement.
时间窗: 35 minutes
Relationship of opioid concentration to pupillary unrest, measured by the pupillometer
次要结局
- Impact of environmental stimulation on opioid-related deviations in pupillary measurements.(35 minutes)