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

NCT04301895 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-03-10

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Rachel Eshima McKay, M.D. · Professor of Anesthesia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2019-09-03
Completion
2019-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301895 on ClinicalTrials.gov