At a glance
ClinicalIndex Comparison Record- ✓Healthy individuals
- ✓BMI less than 35 kg/m²
- ✓Age 40-60 years
- ✕Current or recent opioid use
- ✕Opioid or other substance use disorder
- ✕Known or suspected obstructive sleep apnea or sleep disordered breathing
- ✕History of ischemic heart disease, heart failure, or symptomatic arrhythmia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
In Brief
A Phase 3 clinical trial evaluating Remifentanil Hydrochloride and Pupillometry measurement for Opioid Toxicity and 2 related conditions. Completed, enrolled 10 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes.
Pupillary measurements were taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.