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Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Sponsor: Massachusetts General Hospital
Summary
This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2025-01-06
Completion Date
2029-03-31
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
Intravenous Dexmedetomidine
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Sublingual Dexmedetomidine
Sublingual dexmedetomidine (120 μg)
Intravenous Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
Sublingual Placebo
Inert sublingual film
Locations (14)
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Iowa Carver College of Medicine
Iowa City, Iowa, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States