Respiratory Depression Clinical Trial
Official title:
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. — View Citation
McKay RE, Larson MD. Detection of opioid effect with pupillometry. Auton Neurosci. 2021 Nov;235:102869. doi: 10.1016/j.autneu.2021.102869. Epub 2021 Aug 18. — View Citation
McKay RE, Neice AE, Larson MD. Pupillary Unrest in Ambient Light and Prediction of Opioid Responsiveness: Case Report on Its Utility in the Management of 2 Patients With Challenging Acute Pain Conditions. A A Pract. 2018 May 15;10(10):279-282. doi: 10.1213/XAA.0000000000000710. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Time Concentration Curve (AUC 0-35 minutes) | PUAL measured by pupillometer. | Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery |
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