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NCT04466384 · ClinicalTrials.gov registry record · NA
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
A NA study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT04466384: Completed NA study, sponsored by Medtronic - MITG.
NCT04466384 is a NA study that has completed, run by Medtronic - MITG. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04466384, a NA study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
Primary Outcome
To determine BIS50 (BIS™ value at which 50% of patients will be unresponsive at given drug concentrations) and other dose-response parameters. BIS™ is a scale 0-100 with values near 100 represent an "awake" clinical state while 0 denotes the maximal EEG effect possible (i.e., an isoelectric EEG). Responsiveness is measured using the Modified Observer's Assessment of Alertness/ Sedation (MOAA/S). Below a MOAA/S of 2, responsiveness is measured with Tetanic Electrical Stimulation (TES). The subjec
Interventions
- DEVICE BIS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2021-03-03 |
| Phase | NA |
What the finished NCT04466384 record still lists
NCT04466384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which BIS is the first listed.
NCT04466384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04466384 about?
NCT04466384 is a clinical study titled "Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)". The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
What is the current status of trial NCT04466384?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2020-08-11. Estimated completion is 2021-03-03.
What interventions are being tested in trial NCT04466384?
The interventions under investigation include: BIS (DEVICE).
Who is sponsoring clinical trial NCT04466384?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04466384's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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