Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Massachusetts General Hospital
1,800 participants
Jan 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria9
- 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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Interventions
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Sublingual dexmedetomidine (120 μg)
Intravenous placebo of 0.9% saline administered over 40 minutes
Inert sublingual film
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06192615