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Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

Respiratory Depression Clinical Trial

Official title:
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05391555
Study type Interventional
Source University of California, San Francisco
Contact Rachel Eshima McKay, MD
Phone 415-502-1715
Email rachel.eshima@ucsf.edu
Status Recruiting
Phase Phase 2/Phase 3
Start date October 1, 2022
Completion date August 31, 2023
View Details
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