NCT03284307

UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

\* 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 midazolam (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.

Conditions

• Unconsciousness
• Consciousness

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	20 participants will be administered Dexmedetomidine.
DRUG	Ketamine	20 participants will be administered Ketamine.
DRUG	Propofol	20 participants will be administered Propofol.
DRUG	Midazolam	20 participants will be administered Midazolam.

Timeline

• Start date: 2017-08-10
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2017-09-15
• Last updated: 2023-04-13
• Results posted: 2023-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study