Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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) - History of obstructive sleep apnea - 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Intravenous Dexmedetomidine
    Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
    Other names:
    • Intravenous Precedex
  • Drug: Sublingual Placebo
    Inert sublingual film
    Other names:
    • Placebo
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.
  • Drug: Sublingual Dexmedetomidine
    Sublingual dexmedetomidine (120 μg)
    Other names:
    • Sublingual Precedex
  • Drug: Intravenous Placebo
    Intravenous placebo of 0.9% saline administered over 40 minutes
    Other names:
    • Placebo
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.
  • Drug: Intravenous Placebo
    Intravenous placebo of 0.9% saline administered over 40 minutes
    Other names:
    • Placebo
  • Drug: Sublingual Placebo
    Inert sublingual film
    Other names:
    • Placebo

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Amit Bardia, MD

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Oluwaseun Johnson-Akeju, MD
617-726-3030
ojohnsonakeju@partners.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.