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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-06-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Opioid Toxicity Pupillary Miosis Respiratory Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Remifentanil Hydrochloride

Intervention Type DRUG

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

Pupillometry measurement

Intervention Type DEVICE

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

Interventions

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Remifentanil Hydrochloride

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

Intervention Type DRUG

Pupillometry measurement

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes