Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Purpose
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.
Conditions
- Opioid Toxicity
- Pupillary Miosis
- Respiratory Depression
Eligibility
- Eligible Ages
- Between 40 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
- Masking Description
- The investigator determining the PUAL will be blinded to the opioid level concurrent with the measurement.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Noninteractive, then Interactive |
Participants undergo the infusion under noninteractive conditions, followed by a second drug infusion under interactive conditions. |
|
|
Experimental Interactive, then Noninteractive |
Participants undergo the infusion under interactive conditions, followed by a second drug infusion under noninteractive conditions. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco
Detailed Description
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.
