Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area Under the Time Concentration Curve (AUROC )
研究概览
简要总结
This study will establish the relationship between magnitude of opioid exposure and a pupillary measure referred to as PUAL (pupillary unrest in ambient light), in subjects aged 40-60. Previous investigation demonstrated that loss of PUAL was a sensitive, discriminative indicator of opioid toxicity and respiratory depression among subjects aged 20-40 years old. Population data indicate that pupil size and PUAL decline slightly with age. The investigators will explore whether PUAL proves to be a sensitive indicator of opioid exposure and respiratory depression in this older group.
详细描述
Healthy volunteer subjects aged 40-60 will receive a standardized weight-based 10-minute remifentanil infusion protocol to achieve a peak estimated remifentanil effect site concentration of approximately 6 ng/mL. Pupillary measures will be taken at baseline and regular time intervals during and after the infusion, over a period of 35 minutes.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, BMI < 35 kg/m2
排除标准
- •current or recent opioid use
- •opioid or other substance use disorder
- •known or suspected OSA or sleep disordered breathing
- •ischemic heart disease, heart failure or symptomatic arrhythmia history
- •ocular disease or previous eye surgery
- •active use of alpha adrenergic blockers, anticholinergic medications,
- •active use of antidepressant or mood stabilizing medications
- •active use of phosphodiesterase inhibitors
- •use of stimulant or appetite suppressant medications
- •active use of antihypertensive or antiarrhythmic medications
- •use of topical eye medications.
研究组 & 干预措施
Remifentanil Infusion and Recovery
Participants underwent a 10-minute remifentanil infusion. Pupillary measures were taken a baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.
干预措施: Remifentanil Hydrochloride (Drug)
Remifentanil Infusion and Recovery
Participants underwent a 10-minute remifentanil infusion. Pupillary measures were taken a baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.
干预措施: Pupillometry measurement (Device)
结局指标
主要结局
Area Under the Time Concentration Curve (AUROC )
时间窗: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery
PUAL measured by pupillometer. PUAL at zero-moderate opioid concentration (\<1.8 ng/mL) versus high-toxic opioid concentration (\>2.5 ng/mL) were dichotomous classifiers. Receiver Operating Characteristic curve constructed, with AUROC reported
次要结局
未报告次要终点