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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301895
• Other study ID #: 221163
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2019
• Est. completion date: September 3, 2019

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy

• Able to provide informed consent

Exclusion Criteria:

• Active substance use disorder

• Prior opioid use disorder

• Opioid use within 30 days.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of environmental stimulation on decline in oxygen saturation to = 90%.	Conversational interaction and oxygen saturation measured by pulse oximeter.	35 minutes
Primary	Impact of environmental stimulation on CO2 increase of 15% or more above baseline.	Conversational interaction and CO2 measured by transcutaneous sensor.	35 minutes
Primary	Correlation between estimated opioid concentration and deviation in pupillary measurement.	Relationship of opioid concentration to pupillary unrest, measured by the pupillometer	35 minutes
Secondary	Impact of environmental stimulation on opioid-related deviations in pupillary measurements.	Impact of conversational interaction on degree of decline in pupillary unrest as measured by the pupillometer.	35 minutes