Purpose of this Study
We are doing this study to find out if nighttime dosing of a sedative called dexmedetomidine (the study drug) can reduce the occurrence of delirium (a state of mental confusion) in older adults who have heart surgery.
Who Can Participate?
Eligibility
Adults ages 60+ who:
- Are scheduled for heart surgery with cardiopulmonary bypass
- Plan to recover in the ICU after surgery
- Do not have a diagnosis of Alzheimer's Disease or related dementia, severe cognitive impairment, or delirium
- Have no history of obstructive sleep apnea
Age Range
60-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Get a random assignment (by chance) to get the study drug as either an IV infusion or a dissolvable strip you take by mouth, or get a placebo (inactive substance) as either an IV infusion or dissolvable strip you take by mouth
- Get the study drug or placebo in the same manner the day after your surgery and answer questionnaires, have memory testing done, and have a blood sample collected
- Get the study drug or placebo in the same manner 2 days after your surgery and answer questionnaires and have memory testing done
- Answer questionnaires and have memory testing done on days 3-7 after your surgery
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS II)
Principal Investigator
Mihai
Podgoreanu
Protocol Number
PRO00116434
NCT ID
NCT06192615
Phase
III
Enrollment Status
Open to Enrollment