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NCT04301895 · ClinicalTrials.gov registry record · Phase 1
Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
A Phase 1 study of Acute Pain and Safety Issues, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04301895: Completed Phase 1 study of Acute Pain and Safety Issues, sponsored by University of California, San Francisco.
NCT04301895 is a Phase 1 study of Acute Pain and Safety Issues that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 268-participant average among 50 other Acute Pain trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04301895, a Phase 1 study of Acute Pain and Safety Issues, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Conversational interaction and oxygen saturation measured by pulse oximeter.
Conditions Studied
Interventions
- BEHAVIORAL Continuous conversational interaction
- DRUG Remifentanil infusion
Study Locations (1)
California
- University of California San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2019-09-03 |
| Phase | Phase 1 |
What the finished NCT04301895 record still lists
NCT04301895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 268-participant average among 50 other Acute Pain trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Acute Pain appearing as the primary indexed condition, and to 2 interventions - of which Continuous conversational interaction is the first listed.
NCT04301895 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04301895 about?
NCT04301895 is a clinical study titled "Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression". 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 wash...
What is the current status of trial NCT04301895?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-04-30. Estimated completion is 2019-09-03.
What conditions does trial NCT04301895 study?
This clinical trial studies the following conditions: Acute Pain, Safety Issues, Respiratory Depression, Overdose of Opiate, Opioid; Intoxication, Perception Disturbance (Acute).
What interventions are being tested in trial NCT04301895?
The interventions under investigation include: Continuous conversational interaction (BEHAVIORAL), Remifentanil infusion (DRUG).
Who is sponsoring clinical trial NCT04301895?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04301895 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04301895's enrollment target sits among peer trials
20 48th of 50 higher than 1 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain 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.
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