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NCT05391555 · ClinicalTrials.gov registry record · Phase 2
Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT05391555: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT05391555 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05391555, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
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.
Primary Outcome
PUAL measured by pupillometer. PUAL at zero-moderate opioid concentration (\<1.8 ng/mL) versus high-toxic opioid concentration (\>2.5 ng/mL) were dichotomous classifiers. Receiver Operating Characteristic curve constructed, with AUROC reported
Interventions
- DRUG Remifentanil Hydrochloride
- DEVICE Pupillometry measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2023-06-03 |
| Phase | Phase 2 |
What the finished NCT05391555 record still lists
NCT05391555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Remifentanil Hydrochloride is the first listed.
NCT05391555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05391555 about?
NCT05391555 is a clinical study titled "Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age". 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 ...
What is the current status of trial NCT05391555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2022-10-01. Estimated completion is 2023-06-03.
What interventions are being tested in trial NCT05391555?
The interventions under investigation include: Remifentanil Hydrochloride (DRUG), Pupillometry measurement (DEVICE).
Who is sponsoring clinical trial NCT05391555?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05391555's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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