UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study

Brief Summary

This study will be a single-site, controlled, unblinded study at the University of Wisconsin to examine changes in the electroencephalogram during anesthesia and waking.

Intervention / Treatment

  • Drug: Dexmedetomidine
  • Drug: Ketamine
  • Drug: propofol
  • Drug: Sevoflurane

Condition or Disease

  • Unconsciousness
  • Consciousness

Phase

Study Design

Study type: Interventional
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
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

Lead Sponsor: N/A
Responsible Party: N/A

* 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
Minimum Age: 18
Maximum Age: 40

More Details

NCT Number: NCT03284307
Acronym: UN-CONSCIOUS
Other IDs: 2015-1399|A530900|SMPH\ANESTHESIOLOGY\ANESTHESIO|Protocol Version 10/18/2019
Study URL: https://ClinicalTrials.gov/show/NCT03284307
Last updated: Jan 27, 2021