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NCT04602546 · ClinicalTrials.gov registry record · NA
Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
A NA study of Anesthesia, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 211
- Enrollment target
- 3
- Study locations
NCT04602546: Completed NA study of Anesthesia, sponsored by Medtronic - MITG.
NCT04602546 is a NA study of Anesthesia that has completed, run by Medtronic - MITG. The registered enrollment target is 211 participants, below the 109,407-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04602546, a NA study of Anesthesia, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 211 participants
- Enrollment target
- 3
- Study locations
Study Summary
To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and Desflurane in combination with opioids.
Primary Outcome
To determine BIS50, the BIS™ value (index score on a scale of 0-100 (0 being dead and 100 being fully awake/responsive) on the BIS™ monitor) at which 50% of patients will be unresponsive at a given drug concentration. Responsiveness is measured using the Modified Observer's Assessment of Alertness and Sedation (MOAAS) a 0-5 scale where 0 represents no response to deep stimulus and 5 represents fully awake).
Conditions Studied
Interventions
- DEVICE BIS Complete Monitoring System
Study Locations (3)
California
- University of California at San Francisco - San Francisco
North Carolina
- Duke University Medical Center - Durham
Utah
- University of Utah Health Science Center - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2022-08-26 |
| Phase | NA |
What the finished NCT04602546 record still lists
NCT04602546 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 109,407-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Anesthesia appearing as the primary indexed condition, and to 1 intervention - of which BIS Complete Monitoring System is the first listed.
NCT04602546 reports a single indexed study location in California, North Carolina, Utah.
Frequently Asked Questions
What is clinical trial NCT04602546 about?
NCT04602546 is a clinical study titled "Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)". To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and Desflurane in combination with opioids.
What is the current status of trial NCT04602546?
This trial is currently completed. It is a NA study. The enrollment target is 211 participants. The study started on 2021-02-09. Estimated completion is 2022-08-26.
What conditions does trial NCT04602546 study?
This clinical trial studies the following conditions: Anesthesia.
What interventions are being tested in trial NCT04602546?
The interventions under investigation include: BIS Complete Monitoring System (DEVICE).
Who is sponsoring clinical trial NCT04602546?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04602546 being conducted?
This trial has 3 study locations across California, North Carolina, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04602546's enrollment target sits among peer trials
211 11th of 57 higher than 47 of 57 other Anesthesia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anesthesia 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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