Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Overview
- Phase
- Phase 2
- Intervention
- Remifentanil Hydrochloride
- Conditions
- Opioid Toxicity
- Sponsor
- University of California, San Francisco
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Area Under the Time Concentration Curve (AUROC )
- Status
- Completed
- Last Updated
- last year
Overview
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 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.
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.
Investigators
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
Arms & Interventions
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.
Intervention: Remifentanil Hydrochloride
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.
Intervention: Pupillometry measurement
Outcomes
Primary Outcomes
Area Under the Time Concentration Curve (AUROC )
Time Frame: 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