RecruitingPhase 3NCT06192615

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

Sponsor

Massachusetts General Hospital

Enrollment

1,800 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Delirium

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intravenous Dexmedetomidine, a drug called Intravenous Placebo, and others for people with delirium. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntravenous Dexmedetomidine

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

DRUGSublingual Dexmedetomidine

Sublingual dexmedetomidine (120 μg)

DRUGIntravenous Placebo

Intravenous placebo of 0.9% saline administered over 40 minutes

DRUGSublingual 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

View Full Details on ClinicalTrials.gov

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NCT06192615

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(14)

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