Status:
COMPLETED
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Lead Sponsor:
University of California, San Francisco
Conditions:
Opioid Toxicity
Pupillary Miosis
Eligibility:
All Genders
40-60 years
Phase:
PHASE2
PHASE3
Brief 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 invest...
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 approximat...
Eligibility Criteria
Inclusion
- Healthy, BMI \< 35 kg/m2
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05391555
Start Date
October 1 2022
End Date
June 3 2023
Last Update
May 2 2025
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143