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โ† Trials
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Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

RecruitingPhase 3Ages 60 Years - anyAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Intravenous Dexmedetomidine
  • Sublingual Dexmedetomidine
  • Intravenous Placebo
  • Sublingual Placebo
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Where

14 sites
Cedars-Sinai Medical Center
Los Angeles, United States
University of California San Francisco
San Francisco, United States
Northwestern University Feinberg School of Medicine
Chicago, United States
University of Iowa Carver College of Medicine
Iowa City, United States
University of Maryland School of Medicine
Baltimore, United States
Massachusetts General Hospital
Boston, United States
Beth Israel Deaconess Medical Center
Boston, United States
Brigham and Women's Hospital
Boston, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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