Summary

Eligibility
for people ages 40-60 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Details

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.

Keywords

Opioid Toxicity, Pupillary Miosis, Respiratory Depression, Respiratory Insufficiency, Miosis, Remifentanil, Remifentanil Hydrochloride, Pupillometry measurement, Noninteractive, then Interactive, Interactive, then Noninteractive

Eligibility

You can join if…

Open to people ages 40-60

  • Healthy, BMI < 35 kg/m2

You CAN'T join if...

  • 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.

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05391555
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated