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Completed

NCT Number: NCT04301895

Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression

Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence versus absence of verbal interaction.

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Key information

Conditions

Opioid; Intoxication, Perception Disturbance (Acute) Acute Pain Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opiate Overdose Opioid-Related Disorders Overdose of Opiate Pain Pathological Conditions, Signs and Symptoms Prescription Drug Misuse Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Safety Issues Signs and Symptoms Substance-Related Disorders

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

Healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for 10 minutes. Vital signs including SpO2, transcutaneous CO2, and respiratory rate will be continuously measured.

In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence of ongoing verbal interaction versus complete avoidance of verbal interaction.

Incidence of respiratory depression will be compared in the two protocols with or without verbal interaction. Correlation between pupil diameter and pupillary unrest with estimated opioid concentrations will be determined by regression. Difference between pupil measurement versus opioid concentration regressions will be compared by chi2.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • Able to provide informed consent

Exclusion criteria

  • Active substance use disorder
  • Prior opioid use disorder
  • Opioid use within 30 days.

Treatment and study plan

Continuous conversational interaction

Behavioral

Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.

Other names: Environmental stimulation

Remifentanil infusion

Drug

10 minute remifentanil infusion

Primary outcomes

  1. Impact of environmental stimulation on decline in oxygen saturation to ≤ 90%.

    Time frame: 35 minutes

    Conversational interaction and oxygen saturation measured by pulse oximeter.

  2. Impact of environmental stimulation on CO2 increase of 15% or more above baseline.

    Time frame: 35 minutes

    Conversational interaction and CO2 measured by transcutaneous sensor.

  3. Correlation between estimated opioid concentration and deviation in pupillary measurement.

    Time frame: 35 minutes

    Relationship of opioid concentration to pupillary unrest, measured by the pupillometer

Secondary outcomes

  1. Impact of environmental stimulation on opioid-related deviations in pupillary measurements.

    Time frame: 35 minutes

    Impact of conversational interaction on degree of decline in pupillary unrest as measured by the pupillometer.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression in Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2020
Registry last updated
Mar 10, 2020

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.

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