Remifentanil Hydrochloride for Miosis disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California San Francisco, San Francisco, CA
Miosis disorder+4 More
Remifentanil Hydrochloride - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Miosis disorder
  • Opioid Toxicity
  • Respiratory Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery

Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery
Area Under the Time Concentration Curve (AUC 0-35 minutes)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Interactive, then Noninteractive
1 of 2
Noninteractive, then Interactive
1 of 2
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Remifentanil Hydrochloride · No Placebo Group · Phase 2 & 3

Interactive, then NoninteractiveExperimental Group · 2 Interventions: Pupillometry measurement, Remifentanil Hydrochloride · Intervention Types: Device, Drug
Noninteractive, then InteractiveExperimental Group · 2 Interventions: Pupillometry measurement, Remifentanil Hydrochloride · Intervention Types: Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remifentanil Hydrochloride
2020
Completed Phase 4
~230

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery
Closest Location: University of California San Francisco · San Francisco, CA
Photo of University of California San Francisco 1Photo of university of california san francisco 2Photo of University of California San Francisco 3
2001First Recorded Clinical Trial
0 TrialsResearching Miosis disorder
345 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,246 Previous Clinical Trials
11,473,654 Total Patients Enrolled
Rachel Eshima McKay, MDPrincipal InvestigatorProfessor of Anesthesia

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.