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NCT06192615PHASE3Recruiting

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

Massachusetts General Hospital

Start Date

1/6/2025

Completion Date

3/31/2029

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.

Eligibility Criteria

Age Range: 60 years to No maximum

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

Interventions

DRUG

Intravenous Dexmedetomidine

DRUG

Sublingual Dexmedetomidine

DRUG

Intravenous Placebo

DRUG

Sublingual Placebo

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Conditions

Delirium

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of California San Francisco

San Francisco, California 94117

United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois 60611

United States

University of Iowa Carver College of Medicine

Iowa City, Iowa 522421320

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Brigham and Women's Hospital

Boston, Massachusetts 02215

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Columbia University Medical Center

New York, New York 10032

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Duke University Hospital

Durham, North Carolina 27710

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States