Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
NCT ID: NCT04301895
Last Updated: 2020-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2019-04-30
2019-09-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Interactive
Subject will be asked to continually interactive with the investigators, answering a series of standard questions during the remifentanil infusion and recovery periods.
Continuous conversational interaction
Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.
Remifentanil infusion
10 minute remifentanil infusion
Non-interactive
All verbal interaction will be avoided and extraneous sounds will be eliminated from the environment during the remifentanil infusion and recovery periods.
Remifentanil infusion
10 minute remifentanil infusion
Interventions
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Continuous conversational interaction
Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.
Remifentanil infusion
10 minute remifentanil infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
Exclusion Criteria
* Prior opioid use disorder
* Opioid use within 30 days.
20 Years
55 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Rachel Eshima McKay, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor of Anesthesia
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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McKay RE, Kohn MA, Larson MD. Pupillary unrest, opioid intensity, and the impact of environmental stimulation on respiratory depression. J Clin Monit Comput. 2022 Apr;36(2):473-482. doi: 10.1007/s10877-021-00675-3. Epub 2021 Mar 2.
Other Identifiers
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221163
Identifier Type: -
Identifier Source: org_study_id
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