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

Last updated: January 6, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Dementia

Treatment

Sublingual Dexmedetomidine

Sublingual Placebo

Intravenous Dexmedetomidine

Clinical Study ID

NCT06192615
2023P003359
  • Ages > 60
  • All Genders

Study 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

Inclusion

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

Exclusion Criteria:

  • Allergy or hypersensitivity to dexmedetomidine or the placebo study medication

  • Preexisting diagnosis of Alzheimer's Disease or Related Dementia, severe cognitiveimpairment or delirium at baseline

  • Severe liver failure (Child-Pugh score > 5)

  • History of obstructive sleep apnea

  • 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 siteinvestigator and/or PI, might interfere with study participation, collection, orinterpretation of the study data

Study Design

Total Participants: 1800
Treatment Group(s): 4
Primary Treatment: Sublingual Dexmedetomidine
Phase: 3
Study Start date:
January 06, 2025
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa Carver College of Medicine

    Iowa City, Iowa 522421320
    United States

    Site Not Available

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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