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

• Status: Not yet recruiting
• Trial end date: 2029-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Dexmedetomidine

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