Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Delirium

In brief

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 facts

Study ID

NCT06192615

Run by

Massachusetts General Hospital

People needed

1800

Starts

2025-01-06

Expected to finish

2029-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 60 years or older
• Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
• Planned postoperative admission to the intensive care unit (ICU)

You may not qualify if…

• Allergy or hypersensitivity to dexmedetomidine or the placebo study medication
• Preexisting diagnosis of Alzheimer's Disease or Related Dementia, severe cognitive impairment or delirium at baseline
• Severe liver failure (Child-Pugh score > 5)
• Severe deficit(s) due to structural or anoxic brain damage
• Undergoing a surgical procedure requiring total circulatory arrest
• SARS-CoV-2 positive or symptomatic (e.g., fever, cough, loss of taste/smell)
• Blind, deaf, or unable to communicate in English
• Patients experiencing circumstances for which long-term follow-up might be difficult (e.g., homelessness, active psychotic disorder, or substance abuse)
• Co-enrollment in other interventional studies that, in the opinion of the site investigator and/or PI, might interfere with study participation, collection, or interpretation of the study data

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
• University of Iowa Carver College of Medicine — Iowa City, Iowa, United States (enrolling)
• University of Maryland School of Medicine — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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