Recruiting
Phase 3

Dexmedetomidine

Sponsor:

Massachusetts General Hospital

Code:

NCT06192615

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Intravenous Dexmedetomidine

Sublingual Dexmedetomidine

Intravenous Placebo

Sublingual Placebo

Study Details

Brief 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.

Conditions

Delirium

Study ID

NCT06192615

Start date

Jan 6, 2025

Status verified date

Jul, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intravenous Dexmedetomidine

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.

experimental: Sublingual Dexmedetomidine

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.

placebo comparator: Placebo

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.

Interventions

Intravenous Dexmedetomidine

Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)

Sublingual Dexmedetomidine

Sublingual dexmedetomidine (120 μg)

Intravenous Placebo

Intravenous placebo of 0.9% saline administered over 40 minutes

Sublingual Placebo

Inert sublingual film

Primary outcome measure

  • Delirium [ Time Frame: Postoperative day 1 ]

Central Contacts and Locations

Central contacts

Oluwaseun Johnson-Akeju, MD

617-726-3030ojohnsonakeju@partners.org

Ariel Mueller, MA

6177269252almueller@mgh.harvard.edu

Locations

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

University of Iowa Carver College of Medicine

Recruiting

Iowa City, Iowa, United States, 522421320

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-06.