MINDDS II (Heart Surgery Recovery) - Clinical Trial
What is the 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.
What is the Condition Being Studied?
Recovery From Heart Surgery
Who Can Participate in the Study?
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
For more information, contact the study team at emmalee.metzler@duke.edu.
Age Group
Adults
What is Involved?
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
After you return home, we will call you around 1 month, 6 months, and 1 year after your surgery to see how you are doing and ask you questions about your thinking and memory.
Study Details
Full Title
Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS II)
Principal Investigator
Anesthesiologist
Protocol Number
IRB:
PRO00116434
NCT:
NCT06192615
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment