Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2019
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedMarch 10, 2020
March 1, 2020
4 months
March 3, 2020
March 5, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Impact of environmental stimulation on decline in oxygen saturation to ≤ 90%.
Conversational interaction and oxygen saturation measured by pulse oximeter.
35 minutes
Impact of environmental stimulation on CO2 increase of 15% or more above baseline.
Conversational interaction and CO2 measured by transcutaneous sensor.
35 minutes
Correlation between estimated opioid concentration and deviation in pupillary measurement.
Relationship of opioid concentration to pupillary unrest, measured by the pupillometer
35 minutes
Secondary Outcomes (1)
Impact of environmental stimulation on opioid-related deviations in pupillary measurements.
35 minutes
Study Arms (2)
Interactive
OTHERSubject will be asked to continually interactive with the investigators, answering a series of standard questions during the remifentanil infusion and recovery periods.
Non-interactive
OTHERAll verbal interaction will be avoided and extraneous sounds will be eliminated from the environment during the remifentanil infusion and recovery periods.
Interventions
Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.
Eligibility Criteria
You may qualify if:
- Healthy
- Able to provide informed consent
You may not qualify if:
- Active substance use disorder
- Prior opioid use disorder
- Opioid use within 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
Related Publications (1)
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.
PMID: 33651243DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Eshima McKay, M.D.
Professor of Anesthesia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 10, 2020
Study Start
April 30, 2019
Primary Completion
September 3, 2019
Study Completion
September 3, 2019
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share