Medtronic BIS (SONORA) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how well the study device (the Bispectral Index monitoring system) measures brain activity in a person that is under anesthesia (being medically asleep).

The Bispectral Index monitoring (BIS) can help anesthesiologists (Doctor that gives you anesthesia) know how much medicine needs to be given to reach the best level of sedation.

What is the Condition Being Studied?

Healthy Volunteers

Who Can Participate in the Study?

-Healthy Men and Women, 18-60 years old

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Complete 3 visits to the Duke Clinic (first visit will be 2 hours and the other two will be 4 hours)
-Complete 2 follow-up phone calls
-Have a physical exam
-Have blood tests
-Give urine samples
-Have your vitals taken (heart rate, blood pressure etc.)

During visits 2 and 3 you will:
-Be placed under anesthesia (medically put to sleep) while wearing the study device (Bispectral Index monitoring system)on your forehead

If you are interested in participating, please click on this link and we will contact you:
https://redcap.duke.edu/redcap/surveys/?s=AR9HNRHAMH

Study Details

Full Title
Bispectral Index and Levels of Sedation with Propofol with/without Remifentanil in Healthy Volunteers (SONORA)
Principal Investigator
Protocol Number
IRB: PRO00104755
NCT: NCT04466384
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698