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

April 30, 2025 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Remifentanil Hydrochloride
Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes.
Device: Pupillometry measurement
Pupillary measurements were taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Rachel Eshima McKay, MD, professor of anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

June 3, 2023

Study Completion (Actual)

June 3, 2023

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-34917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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