MDT19053OLIVER - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the relationship between Bispectral Index (the sticker used on your forehead) and inhaled medication that will be used to put you to sleep.

The Bispectral Index (BIS) monitoring system is designed to monitor the level of sedation by a sticker placed on the forehead.

What is the Condition Being Studied?

Healthy Volunteers

Who Can Participate in the Study?

Healthy Volunteers who are:
-Between the ages of 18 and 60
-Do not smoke and can pass a drug test
-Do not take any medications on a regular basis
-Do not have brain, heart or lung diseases

Age Group
Adults

What is Involved?

If you choose to join this study, you will have 2 in-person visits.

During visit 1 you will:
-Complete a health questionnaire
-Have a medical exam
-Have a heart test (EKG)
-Have urine/blood tests

During visit 2, you will:
-Be sedated (put to sleep) at doses sufficient
-Have a sticker placed on your forehead to measure how awake and alert you are as the sedation medicine is given

For more information, or to sign up, visit us here: https://redcap.duke.edu/redcap/surveys/?s=E3E99CHXFY

Study Details

Full Title
Evaluation of BIS™ and Levels of Sedation with Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
Principal Investigator
Protocol Number
IRB: PRO00106916
NCT: NCT04602546
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