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

Mass General Brigham

Status and phase: Enrolling; Phase 3

Conditions: Delirium

Treatments: Drug: Intravenous Dexmedetomidine; Drug: Sublingual Dexmedetomidine; Drug: Sublingual Placebo; Drug: Intravenous Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06192615

2023P003359

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,800 participants in 3 patient groups, including a placebo group

Intravenous Dexmedetomidine

Experimental group

Description:

After admission to the ICU and discontinuation of mechanical ventilation, intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit.

Treatment:

Drug: Sublingual Placebo

Drug: Intravenous Dexmedetomidine

Sublingual Dexmedetomidine

Experimental group

Description:

After admission to the ICU and discontinuation of mechanical ventilation, sublingual dexmedetomidine (120 μg) and an intravenous placebo (0.9% saline over 40 minutes) will be administered nightly for the first three nights while the patient is in the intensive care unit.

Treatment:

Drug: Intravenous Placebo

Drug: Sublingual Dexmedetomidine

Placebo

Placebo Comparator group

Description:

After admission to the ICU and discontinuation of mechanical ventilation, an intravenous placebo (0.9% saline over 40 minutes) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit.

Treatment:

Drug: Intravenous Placebo

Drug: Sublingual Placebo