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RECRUITING
NCT06192615
PHASE3

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

DRUG

Intravenous Dexmedetomidine

Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)

DRUG

Sublingual Dexmedetomidine

Sublingual dexmedetomidine (120 μg)

DRUG

Intravenous Placebo

Intravenous placebo of 0.9% saline administered over 40 minutes

DRUG

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