Clinical trial NCT05391555: Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Official title: Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Opioid Toxicity
Pupillary Miosis
Respiratory Depression
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Healthy volunteer subjects aged 40-60 will receive a standardized weight-based 10-minute remifentanil infusion protocol to achieve a peak estimated remifentanil effect site concentration of approximately 6 ng/mL. Pupillary measures will be taken at baseline and regular time intervals during and after the infusion, over a period of 35 minutes.

Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Time Concentration Curve (AUROC )
timeFrame: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: Professor of Anesthesia
name: Rachel Eshima McKay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.