Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Baltimore, Boston, Chicago, Durham, Iowa City, Los Angeles, Nashville, New York, Omaha, San Francisco, St Louis, and The Bronx, United StatesSee the 14 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,800 people, planned
- Started
- 6 Jan 2025
- Expected to end
- 31 Mar 2029
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Intravenous Dexmedetomidine
- Sublingual Dexmedetomidine
- Intravenous Placebo
- Sublingual Placebo
- Record updated
- 14 September 2026
Who can take part
- Age
- 60 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Aged 60 years or older
- Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
- Planned postoperative admission to the intensive care unit (ICU)
Who cannot take part
- Undergoing a surgical procedure requiring total circulatory arrest
- 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)
- Patients experiencing circumstances for which long-term follow-up might be difficult (e.g., homelessness, active psychotic disorder, or substance abuse)
- Severe deficit(s) due to structural or anoxic brain damage
- SARS-CoV-2 positive or symptomatic (e.g., fever, cough, loss of taste/smell)
- Blind, deaf, or unable to communicate in English
- 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
Where in United States
- University of Maryland School of MedicineBaltimore, United StatesContact: Patrick Odonkor, MDTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Shahzad Shaefi, MDTaking people
- Brigham and Women's HospitalBoston, United StatesContact: Oluwaseun Johnson-Akeju, MDTaking people
- Massachusetts General HospitalBoston, United StatesContact: Amit Bardia, MDTaking people
- Northwestern University Feinberg School of MedicineChicago, United StatesContact: Charles Hogue, MDTaking people
- Duke University HospitalDurham, United StatesContact: Mihai Podgoreanu, MDTaking people
- University of Iowa Carver College of MedicineIowa City, United StatesContact: Andrew Feider, MDTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Abirami Kumaresan, MDNot yet recruiting
- Vanderbilt University Medical CenterNashville, United StatesContact: Frederic T Billings, MDTaking people
- Columbia University Medical CenterNew York, United StatesContact: Vivek Moitra, MDTaking people
- University of Nebraska Medical CenterOmaha, United StatesContact: Shaun Thompson, MDTaking people
- University of California San FranciscoSan Francisco, United StatesContact: Matthieu Legrand, MDTaking people
- Washington University School of MedicineSt Louis, United StatesContact: Ben Palanca, MDTaking people
- Montefiore Medical CenterThe Bronx, United StatesContact: Matthias Eikermann, MDTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Intravenous DexmedetomidineTreatment being tested
After admission to the ICU and discontinuation of mechanical ventilation, intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit.
Treatment: Intravenous Dexmedetomidine and Sublingual Placebo
- Sublingual DexmedetomidineTreatment being tested
After admission to the ICU and discontinuation of mechanical ventilation, sublingual dexmedetomidine (120 μg) and an intravenous placebo (0.9% saline over 40 minutes) will be administered nightly for the first three nights while the patient is in the intensive care unit.
Treatment: Sublingual Dexmedetomidine and Intravenous Placebo
- PlaceboPlacebo, for comparison
After admission to the ICU and discontinuation of mechanical ventilation, an intravenous placebo (0.9% saline over 40 minutes) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit.
Treatment: Intravenous Placebo and Sublingual Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 September 2026