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
- Intravenous Dexmedetomidine (drug)
- Sublingual Dexmedetomidine (drug)
- Intravenous Placebo (drug)
- Sublingual Placebo (drug)
Sponsor: Massachusetts General Hospital · Participants: 1,800 · Started: Jan 6, 2025
Contact the study team
- Oluwaseun Johnson-Akeju, MD · Phone: 617-726-3030
- Ariel Mueller, MA · Phone: 6177269252
Official record on ClinicalTrials.gov — NCT06192615
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.