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

RecruitingPhase 3

Who can join

Ages 60 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Massachusetts General Hospital · Participants: 1,800 · Started: Jan 6, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06192615

Locations in the U.S.

CaliforniaCedars-Sinai Medical Center, Los Angeles (Not yet recruiting)
University of California San Francisco, San Francisco
IllinoisNorthwestern University Feinberg School of Medicine, Chicago
IowaUniversity of Iowa Carver College of Medicine, Iowa City
MarylandUniversity of Maryland School of Medicine, Baltimore
MassachusettsBeth Israel Deaconess Medical Center, Boston
Brigham and Women's Hospital, Boston
Massachusetts General Hospital, Boston
MissouriWashington University School of Medicine, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New YorkColumbia University Medical Center, New York
Montefiore Medical Center, The Bronx
North CarolinaDuke University Hospital, Durham
TennesseeVanderbilt University Medical Center, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.