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Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

NCT06192615

RecruitingPhase 3

Sponsor: Massachusetts General Hospital

Conditions: Delirium

Interventions: Intravenous Dexmedetomidine, Sublingual Dexmedetomidine, Intravenous Placebo, Sublingual Placebo

Countries: United States

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 overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (14)
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Nashville, Tennessee, United States