UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study
Brief Summary
Condition or Disease
- Unconsciousness
- Consciousness
Phase
Study Design
Study type: | Interventional |
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Status: | Suspended |
Study results: | No Results Available |
Age: | 18 Years to 40 Years (Adult) |
Enrollment: | 80 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Aug 10, 2017 | |
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Primary Completion: | Aug 10, 2021 | |
Completion Date: | Aug 10, 2021 | |
Study First Posted: | Sep 15, 2017 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Jun 19, 2020 |
Sponsors / Collaborators
Location
* 20 subjects will be recruited per drug, and subjects can be recruited to undergo multiple sedation protocols.
Screening:
Subjects will respond to the volunteer posts for the study by calling into a study specific phone number. They will complete a phone screening to determine basic eligibility for the study. At the beginning of the sedation session, participants will affirm that in the interval since their baseline visit, they have not acquired any of the cited exclusion criteria that would preclude participation. A review of these exclusion criteria will be completed by the Anesthesiologist. A standard pre-anesthetic assessment will be performed, including confirmation of NPO status, and documented using the standard Department of Anesthesiology pre-operative evaluation form.
The first sedative will be dexmedetomidine followed by ketamine, propofol and then sevoflurane (dependent on the availability of the drugs). Total enrollment in the study will be up to 80 subjects. Each sedation experiment will occur on separate days at least 28 days apart, if the subject chooses to participate in more than one session.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 40 |
More Details
NCT Number: | NCT03284307 |
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Acronym: | UN-CONSCIOUS |
Other IDs: | 2015-1399|A530900|SMPH\ANESTHESIOLOGY\ANESTHESIO|Protocol Version 10/18/2019 |
Study URL: | https://ClinicalTrials.gov/show/NCT03284307 |