28
Participants
Start Date
July 31, 2012
Primary Completion Date
June 21, 2019
Study Completion Date
June 21, 2019
Fentanyl
During study visits 2 and 3 you will receive an intrathecal (fluid filled space surrounding the spinal cord) injection of either fentanyl or placebo (saline). Fentanyl is an opiate (narcotic) drug and a common medication, however the way fentanyl is being used in this study is considered investigational.
Catheters
A catheter (small plastic tube placed in a blood vessel) will be placed in an artery in your arm and a second catheter will be placed in a vein in your leg. Local anesthetic will be used to minimize discomfort. These catheters will allow us to measure blood pressure, leg blood flow and draw blood.
Exercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
DEXA
During study visit one you will have a DEXA scan. This procedure requires you to lie on a table while a small x-ray tube passes under your body.
Pulmonary Function Tests
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Blood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Chemosensitivity Test
Using a bag you breath in and out your own air.
Placebo
Mayo Clinic - Saint Marys Hospital, Rochester
Lead Sponsor
Mayo Clinic
OTHER