Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
ConditionDelirium
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
Aged 60 years or older
Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
Planned postoperative admission to the intensive care unit (ICU)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intravenous Dexmedetomidine
- Sublingual Dexmedetomidine
- Intravenous Placebo
- Sublingual Placebo
Treatment groups
1,800 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov