Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Massachusetts General Hospital
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
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
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-…
Interventions
- DrugIntravenous Dexmedetomidine
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
- DrugSublingual Dexmedetomidine
Sublingual dexmedetomidine (120 μg)
- DrugIntravenous Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
- DrugSublingual Placebo
Inert sublingual film
Locations (14)
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Northwestern University Feinberg School of MedicineChicago, Illinois
- University of Iowa Carver College of MedicineIowa City, Iowa
- University of Maryland School of MedicineBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts