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

NCT05391555 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-02

Study results available
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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.

Conditions

  • Opioid Toxicity
  • Pupillary Miosis
  • Respiratory Depression

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Rachel Eshima McKay, MD · Professor of Anesthesia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-06-03
Completion
2023-06-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391555 on ClinicalTrials.gov