Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

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.

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Key information

Conditions

Opioid Toxicity Eye Diseases Miosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pupil Disorders Pupillary Miosis Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remifentanil Hydrochloride

Drug

Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes.

Pupillometry measurement

Device

Pupillary measurements were taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 26, 2022
Registry last updated: May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed