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

March 5, 2020 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

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

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Able to provide informed consent

Exclusion Criteria:

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

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: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Interactive
Subject will be asked to continually interactive with the investigators, answering a series of standard questions during the remifentanil infusion and recovery periods.
Behavioral: Continuous conversational interaction
Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.
Other Names:
  • Environmental stimulation
Drug: Remifentanil infusion
10 minute remifentanil infusion
OTHER: Non-interactive
All verbal interaction will be avoided and extraneous sounds will be eliminated from the environment during the remifentanil infusion and recovery periods.
Drug: Remifentanil infusion
10 minute remifentanil infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of environmental stimulation on decline in oxygen saturation to ≤ 90%.
Time Frame: 35 minutes
Conversational interaction and oxygen saturation measured by pulse oximeter.
35 minutes
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.
35 minutes
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
35 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
35 minutes

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, M.D., 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)

April 30, 2019

Primary Completion (ACTUAL)

September 3, 2019

Study Completion (ACTUAL)

September 3, 2019

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (ACTUAL)

March 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221163

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

No

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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