NCT04301895

Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression

Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression in Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for 10 minutes. Vital signs including SpO2, transcutaneous CO2, and respiratory rate will be continuously measured. 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 of ongoing verbal interaction versus complete avoidance of verbal interaction. Incidence of respiratory depression will be compared in the two protocols with or without verbal interaction. Correlation between pupil diameter and pupillary unrest with estimated opioid concentrations will be determined by regression. Difference between pupil measurement versus opioid concentration regressions will be compared by chi2.

Conditions

• Opioid; Intoxication, Perception Disturbance (Acute)
• Acute Pain
• Overdose of Opiate
• Respiratory Depression
• Safety Issues

Interventions

Type	Name	Description
BEHAVIORAL	Continuous conversational interaction	Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.
DRUG	Remifentanil infusion	10 minute remifentanil infusion

Timeline

• Start date: 2019-04-30
• Primary completion: 2019-09-03
• Completion: 2019-09-03
• First posted: 2020-03-10
• Last updated: 2020-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study