Phase 3
N=10
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Opioid Toxicity · Pupillary Miosis · Respiratory Depression
Bottom Line
View on ClinicalTrials.gov: NCT05391555 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Area Under the Time Concentration Curve (AUROC ) — 0.9700 Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Remifentanil Hydrochloride (Drug); Pupillometry measurement (Device)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Time Concentration Curve (AUROC ) |
0.9700 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy, BMI < 35 kg/m2
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05391555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.