Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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.

Keywords

Delirium, Intravenous Dexmedetomidine, Sublingual Dexmedetomidine

Eligibility

You can join if…

Open to people ages 60 years and up

  • Aged 60 years or older
  • Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
  • Planned postoperative admission to the intensive care unit (ICU)

You CAN'T join if...

  • 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

  • University of California San Francisco not yet accepting patients
    San Francisco California 94117 United States
  • Cedars-Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68198 United States
  • University of Iowa Carver College of Medicine accepting new patients
    Iowa City Iowa 522421320 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
ID
NCT06192615
Phase
Phase 3 Delirium Research Study
Study Type
Interventional
Participants
Expecting 1800 study participants
Last Updated